Clinical T1 Research Articles

Prostate cancer presentation and management in the Middle East

BackgroundAlthough prostate cancer is a prevalent malignancy worldwide, its clinical presentation and management in the Middle East are not well-documented. This study aims to provide insights into the initial clinical presentation and management of prostate cancer in this region.MethodsA retrospective review was conducted on seven institutional databases from six Middle Eastern countries, including Türkiye, Lebanon, Iraq, Syria, Bahrain, and Jordan, to identify patients diagnosed with prostate cancer in 2021. Descriptive analysis was performed on the collected data to provide an overview of the demographic, clinical, and treatment variables.ResultsA total of 1,136 patients were identified with a median age of 70 (range, 50–84). Most patients (78%) received their prostate cancer diagnosis after presenting with symptoms, as opposed to routine PSA screening. At the time of diagnosis, 35% of men had clinical T3 or T4 disease, 54% with Stage IV disease and 50% with Gleason score ≥ 8. Regarding treatment, 20% of non-metastatic and 22% of metastatic patients received no treatment.ConclusionMost men in this study sought prostate cancer evaluation due to symptoms and were subsequently diagnosed with advanced-stage disease, providing a foundation for future research aimed at understanding the underlying factors behind the observed trends and enabling informed interventions.

Transperitoneal vs retroperitoneal laparoscopic radical nephrectomy: a double-arm, parallel-group randomized clinical trial

ObjectiveTo compare the outcomes of patients undergoing Retroperitoneal laparoscopic Radical nephrectomy (RLRN) and Transperitoneal laparoscopic Radical nephrectomy (TLRN).MethodsA total of 120 patients with localized renal cell carcinoma were randomized into either RLRN or TLRN group. Mainly by comparing the patient perioperative related data, surgical specimen integrity, pathological results and tumor results.ResultsEach group comprised 60 patients. The two group were equivalent in terms of perioperative and pathological outcomes. The mean integrity score was significantly lower in the RLRN group than TLRN group. With a median follow-up of 36.4 months after the operation, Kaplan–Meier survival analysis showed no significant difference between RLRN and TLRN in overall survival (89.8% vs. 88.5%; P = 0.898), recurrence-free survival (77.9% vs. 87.7%; P = 0.180), and cancer-specific survival (91.4% vs. 98.3%; P = 0.153). In clinical T2 subgroup, the recurrence rate and recurrence-free survival in the RLRN group was significantly worse than that in the TLRN group (43.2% vs. 76.7%, P = 0.046). Univariate and multivariate COX regression analysis showed that RLRN (HR: 3.35; 95%CI: 1.12–10.03; P = 0.030), male (HR: 4.01; 95%CI: 1.07–14.99; P = 0.039) and tumor size (HR: 1.23; 95%CI: 1.01–1.51; P = 0.042) were independent risk factor for recurrence-free survival.ConclusionsOur study showed that although RLRN versus TLRN had roughly similar efficacy, TLRN outperformed RLRN in terms of surgical specimen integrity. TLRN was also significantly better than RLRN in controlling tumor recurrence for clinical T2 and above cases.Trial registrationChinese Clinical Trial Registry (https://www.chictr.org.cn/showproj.html?proj=24400), identifier: ChiCTR1800014431, date: 13/01/2018.

Construction of a diagnostic nomogram model for predicting the risk of lymph node metastasis in clinical T1 or T2 colon cancer based on the SEER database.

There are few methods related to predicting lymph node metastasis (LNM) in patients with clinically staged T1 or T2 colon cancer. In this study, we aimed to discover independent risk factors for patients with pathologic T-stage 1 (pT1) or pT2 colon cancer with LNM and to develop a nomogram for predicting the probability of LNM for patients with clinically staged T1 or T2 colon cancer. All data were drawn from the Surveillance, Epidemiology, and End Results (SEER) database. Independent risk factors for LNM were identified using univariate and multivariate logistic regression analyses, and these factors were used to construct a nomogram. The discriminatory power, accuracy, and clinical utility of the model were evaluated using receiver operating characteristic (ROC), calibration, and decision curve analysis (DCA), respectively. According to the inclusion and exclusion criteria, 32,803 patients with stage pT1 or pT2 colon cancer who had undergone surgery were selected from the SEER database. The data showed that the incidence of LNM in patients with pT1 and pT2 colon cancer was 17.11%. The age, histological grade, histological type, T classification, M classification, and tumour location were independent risk factors identified through univariate and multivariate analyses, and these factors were used to construct a nomogram. The ROC curve analysis showed that the area under the curve (AUC) of the ROC of the predictive nomogram for LNM risk was 0.6714 [95% confidence interval (CI): 0.6621-0.6806] in the training set and 0.6567 (95% CI: 0.6422-0.6712) in the validation set, indicative of good discriminatory power of the model. Calibration curve analysis demonstrated good agreement between the nomogram prediction and actual observation. DCA showed excellent clinical utility of the prediction model. The incidence of LNM was high in patients with pT1 and pT2 colon cancer. The nomogram established in this study can accurately predict the risk of LNM in patients with clinically staged T1 or T2 colon cancer before further clinical intervention, which allows clinicians to develop optimal treatment.

Phase II study of pembrolizumab in combination with radiation with or without olaparib in localized high-risk prostate cancer.

TPS351 Background: Definitive radiation therapy (DRT) combined with androgen deprivation therapy (ADT) remains the standard of care in patients with high-risk prostate cancer (HRPC) who do not want surgery. However, up to 50% experience biochemical recurrence (BCR) within 5 years. A phase 3 NCIC group reported the 10-year biochemical recurrence free survival was 63% in ADT plus DRT vs. 27% in ADT alone. There is an urgent need for effective novel combination strategies. We hypothesize combined immune sensitizing effects of PARPi and radiation will result in significant activity of immunotherapy in men with HRPC. Methods: This is a multicenter phase II randomized study to assess biochemical response rates, safety and tolerability of combined therapy in pts with localized HRPC who elected for concurrent DRT. A total of 64 pts will be randomized 1:1 to receive either pembrolizumab (P) combined with olaparib or single agent P in addition to the standard of care ADT with DRT. Hypofractionated IMRT (2.4 to 4 Gy per fraction over 4-6 weeks) will be delivered and all pts will receive adjuvant P for one year and ADT for at least 18 months. All pts will undergo germline testing. Key eligible criteria include biopsy confirmed prostate adenocarcinoma who meets at least one of the four high-risk features: 1) clinical T3a, T3b or T4, 2) N1, 3) Gleason grade group 4 or 5, and 4) PSA >20 ng/ml. Patients with less than 2 cm pelvic nodes and received ADT therapy within 3months prior to study enrollment are allowed. PSA >150 ng/ml and patients with distant metastases will be excluded. The primary endpoint is to assess the proportion of patients who achieve a PSA nadir level of ≤ 0.06 ng/ml within six months after completion of radiation therapy in each arm. The secondary objectives include safety/tolerability, BCR and metastasis-free survival at 3 years. BCR is defined by the Phoenix definition. The study is designed to detect a 15% improvement in PSA nadir ≤ 0.06 ng/mL within 6 months after completion of the combined therapy versus historical control group data Geara FB et al., 2017. Enrollment began in August 2023. Clinical trial information: NCT05568550 .

Ultrasonic features of automated breast volume scanner (ABVS) and handheld ultrasound (HHUS) combined with molecular biomarkers in predicting axillary lymph node metastasis of clinical T1-T2 breast cancer.

In the post-American College of Surgeons Oncology Group Z0011 trial era, clinicians are attempting to preoperatively evaluate axillary lymph node (ALN) status using ultrasound. However, the value of preoperative ultrasound examination remains uncertain. The study aimed to investigate the ultrasonic features of automated breast volume scanner (ABVS) and handheld ultrasound (HHUS), in combination with molecular biomarkers, to predict the risk of ALN metastasis (ALNM) in clinical T1-T2 breast cancer. A retrospective case-control analysis was conducted on 168 patients with clinical T1-T2 breast cancer at Peking University First Hospital between January 2013 and August 2021. Preoperative ABVS and HHUS examinations were performed. According to the pathology results of the ALN, patients were divided into metastatic and nonmetastatic groups. Logistic regression analyses were used to analyze the ultrasonic characteristics of ABVS and HHUS on clinical T1-T2 breast cancer, and molecular biomarkers were incorporated to predict the risk of ALNM. Of the 168 patients, 88 (52.4%) had ipsilateral ALNM while 80 (47.6%) had no ipsilateral ALNM. The univariate analysis showed that shorter tumor-skin distance (P=0.011), the Adler blood flow grade of II-III (P=0.014), and larger tumor size on ABVS (P<0.001) were associated with ALNM. The multivariate logistic analysis showed that these three risk factors, including the tumor-skin distance [odds ratio (OR) =0.279; P=0.024], the Adler blood flow grade (OR =2.164; P=0.046), and the tumor size on ABVS (OR =1.033; P=0.002), were independent predictive parameters. The tumor-skin distance, tumor size on ABVS, and Adler blood flow grade have diagnostic value for ALNM in clinical T1-T2 breast cancer.

Clinical T2 N0 M0 Esophageal Cancer: Identifying Predictive Factors of Upstaging

BackgroundInaccuracy of clinical staging renders management of clinical T2 N0 M0 (cT2 N0 M0) esophageal cancer difficult. When an underlying advanced-stage disease is understaged to cT2 N0 M0, patients miss the opportunity to gain the potential benefits of neoadjuvant therapy. This study aimed to identify preoperative factors that predict underlying advanced-stage esophageal cancer. MethodsFrom 2000 to 2020, 1579 patients with esophageal cancer underwent esophagectomy. Sixty patients who underwent upfront surgery for cT2 N0 M0 esophageal cancer were included in this study. The median age was 62.5 years, and 78% (n = 47) of these patients were male. Radiologic, clinical, and endoscopic factors were evaluated as preoperative markers. The Fisher exact and the Wilcoxon rank sum tests were used for categoric and continuous variables, respectively. Random forest classification was used to identify preoperative factors for predicting upstaging and downstaging. ResultsOf the 60 patients, 8 (13%) were found to have pathologic T2 N0 M0 esophageal cancer. Sixteen (27%) patients had cancer that was pathologically downstaged, and 36 (60%) had upstaged disease. Seven (19%) patients had upstaged cancer on the basis of the pathologic T stage, 14 (39%) had upstaging on the basis of the pathologic N stage, and 15 (42%) had upstaging on the basis of both T and N stages. Dysphagia (P = .003) and tumor maximum standardized uptake value (P = .048) were predictors of upstaging, with a combined predictive value of up to 75%. ConclusionsThe presence of dysphagia and of high maximum standardized uptake value (≥5) of the tumor is predictive of more advanced underlying disease for patients with cT2 N0 M0 esophageal cancer, and these patients should be considered for neoadjuvant therapy.

CT features based preoperative predictors of aggressive pathology for clinical T1 solid renal cell carcinoma and the development of nomogram model

BackgroundWe aimed to identify preoperative predictors of aggressive pathology for cT1 solid renal cell carcinoma (RCC) by combining clinical features with qualitative and quantitative CT parameters, and developed a nomogram model.MethodsWe conducted a retrospective study of 776 cT1 solid RCC patients treated with partial nephrectomy (PN) or radical nephrectomy (RN) between 2018 and 2022. All patients underwent four-phase contrast-enhanced CT scans and the CT parameters were obtained by two experienced radiologists using region of interest (ROI). Aggressive pathology was defined as patients with nuclear grade III-IV; upstage to pT3a; type II papillary renal cell carcinoma (pRCC), collecting duct or renal medullary carcinoma, unclassified RCC or sarcomatoid/rhabdoid features. Univariate and multivariate logistic analyses were used to determine significant predictors and develop the nomogram model. To evaluate the accuracy and clinical utility of the nomogram model, we used the receiver operating characteristic (ROC) curve, calibration plot, decision curve analysis (DCA), risk stratification, and subgroup analysis.ResultsOf the 776 cT1 solid RCC patients, 250 (32.2%) had aggressive pathological features. The interclass correlation coefficient (ICC) of CT parameters accessed by two reviewers ranged from 0.758 to 0.982. Logistic regression analyses showed that neutrophil-to-lymphocyte ratio (NLR), distance to the collecting system, CT necrosis, tumor margin irregularity, peritumoral neovascularity, and RER-NP were independent predictive factors associated with aggressive pathology. We built the nomogram model using these significant variables, which had an area under the curve (AUC) of 0.854 in the ROC curve.ConclusionsOur research demonstrated that preoperative four-phase contrast-enhanced CT was critical for predicting aggressive pathology in cT1 solid RCC, and the constructed nomogram was useful in guiding patient treatment and postoperative follow-up.

Minimally invasive surgery for clinical T4 non-small-cell lung cancer: national trends and outcomes.

Recent randomized data support the perioperative benefits of minimally invasive surgery (MIS) for non-small-cell lung cancer (NSCLC). Its utility for cT4 tumours remains understudied. We, therefore, sought to analyse national trends and outcomes of minimally invasive resections for cT4 cancers. Using the 2010-2019 National Cancer Database, we identified patients with cT4N0-1 NSCLC. Patients were stratified by surgical approach. Multivariable logistic analysis was used to identify factors associated with use of a minimally invasive approach. Groups were matched using propensity score analysis to evaluate perioperative and survival end points. The study identified 3715 patients, among whom 64.1% (n = 2381) underwent open resection and 35.9% (n = 1334) minimally invasive resection [robotic-assisted in 31.5% (n = 420); and video-assisted in 68.5% (n = 914)]. Increased MIS use was noted among patients with higher income [≥$40227, odds ratio (OR) 1.24; 95% confidence interval (CI) 1.01-1.51] and those treated at academic hospitals (OR 1.25; 95% CI 1.07-1.45). Clinically node-positive patients (OR 0.68; 95% CI 0.55-0.83) and those who underwent neoadjuvant therapy (OR 0.78; 95% CI 0.65-0.93) were less likely to have minimally invasive resection. In matched groups, patients undergoing MIS had a shorter median length of stay (5 vs 6 days, P < 0.001) and no significant differences between 30-day readmissions or 30/90-day mortality. MIS did not compromise overall survival (log-rank P = 0.487). Nationally, the use of minimally invasive approaches for patients with cT4N0-1M0 NSCLC has increased substantially. In these patients, MIS is safe and does not compromise perioperative outcomes or survival.

Total neoadjuvant therapy (TnT) with FOLFOX followed by short course radiation in locally advanced rectal cancer: A phase II study.

122 Background: Total neoadjuvant therapy (TnT) is a new standard-of-care for locally advanced rectal cancer (LARC). Few prospective studies have evaluated specifically the use of chemotherapy and short course radiation (SCRT) in obtaining a complete clinical response (cCR) and offering non-operative management (NOM). This phase II study sequences FOLFOX followed by SCRT with the primary aim of evaluating the rate of cCR. Methods: Treatment-naïve adults with non-metastatic clinical T2-3N0 or T1-3 with N1-2a rectal adenocarcinoma were eligible to participate in this open label, single-arm clinical trial. Low rectal tumors defined as patients requiring abdominoperineal resection were excluded. This trial evaluated TnT with 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) every 2 weeks for 10-12 cycles followed by SCRT. SCRT consisted of 25 Gy in 5 fractions to rectal tumor and 20 Gy in 5 fractions to lymph node regions. Primary endpoint was the rate of cCR, defined as normal digital rectal exam (DRE) and endoscopic evaluation with normal appearing mucosa or scar but no nodularity or ulcerations. Near complete response (nCR) was defined as DRE with smooth or minor mucosal abnormalities and endoscopic exam with superficial ulceration or erythematous scar. Those with cCR or nCR after TnT were offered NOM and close surveillance; all others underwent total mesorectal excision (TME). Secondary endpoints included 1-year disease-free survival (DFS) from time of cCR (for NOM) or time of TME, overall survival (OS), and R0 surgical resection rate. Results: Twelve patients enrolled with a mean age 51.4 years; 7 were male. Mean distance of the primary tumor from the anal verge was 9.7 cm. Median duration of follow-up was 3.1 years. Three patients (25%) achieved cCR and 1 achieved nCR. All 4 with at least nCR underwent NOM per protocol. The patient with nCR had local regrowth and underwent TME and all 3 patients with cCR remain free of disease on NOM. In regards to secondary outcomes, 1-year DFS was 100%. Median OS was not reached. One patient had died at the time of analysis; this patient had lung nodules thought to be benign at enrollment but ultimately were deemed metastatic disease. All surgical resections were R0 with no local recurrence after TME. The study was closed early after published OPRA trial results demonstrated benefit of giving radiation first in TnT sequencing. Conclusions: Our study suggests that TnT with FOLFOX followed by SCRT may be a valid approach in treating LARC. In this small study, excellent local control was demonstrated with no local recurrence after TME and 25% of pts remaining on NOM at the time of analysis. The 33% of subjects offered NOM is much lower than the published 74% in OPRA, suggesting that chemo followed by SCRT may not be the most optimal approach if organ preservation is the primary treatment aim. Clinical trial information: NCT03781323 .

Tumor regression grade after neoadjuvant chemotherapy in patients with locally advanced gastric cancer treated with modern chemotherapy (FLOT): Experience in patients in Guatemala.

287 Background: Perioperative chemotherapy is the standard of care for locally advanced gastric cancers in Western populations. At this moment perioperative chemotherapy with FLOT (Fluorouracil, leucovorin, oxaliplatin and docetaxel) regimen is recommended in patients who are medically fit with benefit in progression-free survival (PFS) and overall survival (OS). However, the impact of response to this treatment is not well established. The objective of this study is to find the pathological response to FLOT chemotherapy measured by the degree of tumor regression (TRG), the benefit on disease-free survival (DFS) and OS, in patients with gastric cancer locally advanced treated with FLOT chemotherapy. Methods: Patients from the Instituto Guatemalteco de Seguridad Social (IGSS) from Guatemala City, who underwent radical gastrectomy for non-metastatic invasive gastric adenocarcinoma after perioperative chemotherapy (T1-4/N0/N+cM0) from 2019 to 2023 were included. Demographic data, clinical staging, histologic phenotype, surgical factors, tumor regression grade after gastrectomy and survival outcomes were included. The association between ORR and OS were evaluated. OS and DFS were estimated using the Kaplan Meier method with adjustment for covariates using Cox regression. Results: Thirty-eight patients with locally advanced cancer gastric were identified. The median age was 58 years (29-79), most of the patients were men (23, 61%), 35 (92%) patients have primary gastric tumor, 26 (68%) has cT3/T4 tumors and 22 (58%) has intestinal gastric cancer, all patients underwent to surgery. Two patients (6%) had TRG of 1 (complete and almost complete), 8 patients (21%) had an TGR of 2, and 28 patients (74%) had an TGR of 3; 13 patients (38%) developed recurrence, median DFS was 5.2 months (95% CI: 1.0–28). The median OS was 15.3 months (95% CI: 3.0-45). Lack of tumor regression (TRG 3) was significantly associated with lower survival HR 1.42 (1.05-2.24) p= 0.008. Clinical T4 tumors and diffuse histology were associated with poor prognostic (cT4 HR 3.04, p = 0.038, diffuse histology HR 2.08 (p = 0.001) (Table). Conclusions: Since cT4 tumors are an independent risk factor associated with poor prognostic HR 3.04, p = 0.038, it is important to make an adequate clinical staging before deciding to use three-drug treatment regimens of chemotherapy. Other factors in addition to clinical ones should be investigated, such as molecular factors that may be related to this poor response and survival in patients with cT4. This study of molecular factors is currently underway at our institution. [Table: see text]

Survival outcomes in patients with resectable gastric cancer treated with total neoadjuvant therapy.

338 Background: Perioperative chemotherapy is the standard of care for patients diagnosed with advanced gastric cancer. However, the use of total neoadjuvant therapy (TNT), which includes both chemotherapy and chemoradiation, is increasing in other malignancies. The purpose of this study is to determine overall survival (OS) in a contemporary cohort of gastric cancer patients treated with TNT and surgical resection. Methods: Patients diagnosed with microsatellite-stable clinical T2+ or N+ gastric adenocarcinoma (January 2012 to June 2022) were identified from a prospectively maintained institutional database. Those who underwent staging laparoscopy and received neoadjuvant chemotherapy and chemoradiation therapy, followed by gastrectomy, were included in the study. OS and variables associated with OS were determined using standard statistical methods. Results: Of 203 study patients, the median (interquartile range) age was 61 (50-69.5) years and 50 (24.6%) had tumor involving the gastroesophageal junction. The most common TNT sequence was chemotherapy followed by chemoradiation, which was utilized in 173 (85.2%) patients. The chemotherapy regimen typically given was fluorouracil and oxaliplatin in 149 (73.4%) patients. The most common radiation dose was 45 Gy in 25 fractions (169 [83.3%] patients), with 18 (8.9%) patients receiving 30 Gy in 10 fractions. One hundred ninety-seven (97.0%) patients completed all their planned neoadjuvant therapy. Surgical resection included total gastrectomy in 108 (53.2%), adjacent organ resection in 24 (11.8%), and extended (D1+/D2) lymphadenectomy in 193 (95.1%) patients. Pathologic complete response was achieved (pCR) in 32 (15.8%) patients. The median OS was 8.4 (95% confidence interval [CI] 6.5-not reached) years, and the 5-year OS rate was 65.2% (95% CI 57.8-73.5%). Patients with pCR had a 5-year OS rate of 89.1% (95% CI 78.1-100.0%). On multivariable analysis, D1+/D2 lymphadenectomy (HR 0.21 [95% CI 0.088-0.51]), post-treatment pathologic (yp) T (ypT3 vs ypT0, HR 3.11 [95% CI 1.09-8.82]; ypT4 vs ypT0, HR 5.51 [95% CI 1.64-18.5]) and N stages (ypN1 vs ypN0, HR 2.41 [95% CI 1.13-5.13]; ypN2 vs ypN0, HR 2.43 [95% CI 1.14-5.20]; ypN3 vs ypN0, HR 4.70 [95% CI 2.09-10.6]), incidental distant metastasis at time of resection (HR 3.75 [95% CI 1.50-9.37]), and postoperative complications (HR 2.06 [95% CI 1.21-3.52]) were associated with OS. Conclusions: TNT is associated with a high rate of treatment completion and promising long-term OS for patients with resectable gastric cancer. Comparative studies with perioperative treatment and predictors of tumor response will be important in identifying patients suitable for TNT.

Surveillance or Dynamic Sentinel Lymph-Node Biopsy in Low-Risk Clinically N0 Penile Squamous Cell Carcinoma: Single-Institution Real World Data

IntroductionSurveillance is the standard management in low-risk cN0 penile squamous cell carcinoma (peSCC) patients. However, no previous analysis focused on early and long-term outcomes of these patients. We report on main oncological outcomes of a large series of low-risk cN0 peSCC patients. Patients and MethodsBetween 1980 and 2017 included, 93 evaluable consecutive low-risk (ie, pT1a G1 cN0M0) peSCC patients underwent primary tumor surgery and either observation (74) or dynamic sentinel node biopsy (DSNB) (19) following a clinical diagnosis of T1 in 66 (71%), T2 in 15 (16.1%) and Tx in 12 (12.9%) patients, respectively. The statistical significance of differences in medians and proportions was tested with the Kruskal-Wallis and chi-square tests. Kaplan-Meier plots illustrated 5-year inguinal relapse (IR)-free survival rates. ResultsMedian age was 60 years (IQR: 50-69 years). Median follow-up was 92 months (IQR 54-133 months). Surveillance was more frequently adopted in clinical (c)T1 than in cT2 tumors (79.7% vs. 36.8%). None of 19 patients who had DSNB had nodal metastasis. Overall, 7 (7.5%) out of 93 pT1aG1cN0 peSCC patients had IR after a median interval of 9 months. Of note, 1 patient only relapsed after 12 months of surveillance. After stratification according to IR, relapses occurred more frequently in younger patients (59 vs. 64 years, P < .001). The 5-year IR-free survival rates for the entire cohort was 92% (95% Confidence interval [CI] 87-98%). ConclusionsObservation is a safe and effective management for low-risk peSCC patients. Younger patients may be offered a mini-invasive staging as an alternative.

Crop filling: A pipeline for repairing memory clinic MRI corrupted by partial brain coverage

Data-driven solutions offer great promise for improving healthcare. However, standard clinical neuroimaging data is subject to real-world imaging artefacts that can render the data unusable for computational research and quantitative neuroradiology. T1 weighted structural MRI is used in dementia research to obtain volumetric measurements from cortical and subcortical brain regions. However, clinical radiologists often prioritise T2 weighted or FLAIR scans for visual assessment. As such, T1 weighted scans are often acquired but may not be a priority, resulting in artefacts such as partial brain coverage being systematically present in memory clinic data.Here we present “MRI Crop Filling”, a pipeline to replace the missing T1 data with synthetic data generated from the T2 scan, making real-world clinical T1 data usable for computational research including the latest AI innovations. Our method consists of the following steps:•Register scans: T2 and (cropped) T1.•Synthesise a new T1 using an open source deep learning tool.•Replace missing (cropped) T1 data in original T1 scan and super-resolve to improve image quality.

Non-rigid motion-compensated 3D whole-heart T2 mapping in a hybrid 3T PET-MR system.

Simultaneous PET-MRI improves inflammatory cardiac disease diagnosis. However, challenges persist in respiratory motion and mis-registration between free-breathing 3D PET and 2D breath-held MR images. We propose a free-breathing non-rigid motion-compensated 3D T2 -mapping sequence enabling whole-heart myocardial tissue characterization in a hybrid 3T PET-MR system and provides non-rigid respiratory motion fields to correct also simultaneously acquired PET data. Free-breathing 3D whole-heart T2 -mapping was implemented on a hybrid 3T PET-MRI system. Three datasets were acquired with different T2 -preparation modules (0, 28, 55 ms) using 3-fold undersampled variable-density Cartesian trajectory. Respiratory motion was estimated via virtual 3D image navigators, enabling multi-contrast non-rigid motion-corrected MR reconstruction. T2 -maps were computed using dictionary-matching. Approach was tested in phantom, 8 healthy subjects, 14 MR only and 2 PET-MR patients with suspected cardiac disease and compared with spin echo reference (phantom) and clinical 2D T2 -mapping (in-vivo). Phantom results show a high correlation (R2 = 0.996) between proposed approach and gold standard 2D T2 mapping. In-vivo 3D T2 -mapping average values in healthy subjects (39.0 ± 1.4 ms) and patients (healthy tissue) (39.1 ± 1.4 ms) agree with conventional 2D T2 -mapping (healthy = 38.6 ± 1.2 ms, patients = 40.3 ± 1.7 ms). Bland-Altman analysis reveals bias of 1.8 ms and 95% limits of agreement (LOA) of -2.4-6 ms for healthy subjects, and bias of 1.3 ms and 95% LOA of -1.9 to 4.6 ms for patients. Validated efficient 3D whole-heart T2 -mapping at hybrid 3T PET-MRI provides myocardial inflammation characterization and non-rigid respiratory motion fields for simultaneous PET data correction. Comparable T2 values were achieved with both 3D and 2D methods. Improved image quality was observed in the PET images after MR-based motion correction.

Primary Surgery Followed by Selective Chemoradiotherapy Versus Preoperative Chemoradiotherapy Followed by Surgery for Locally Advanced Rectal Cancer: A Randomized Clinical Trial

The aim of this work was to determine whether locally advanced rectal cancer (LARC) with negative mesorectal fascia (MRF) predicted by magnetic resonance imaging (MRI) can be excluded from preoperative radiation therapy treatment. This multicenter, open-label, non-inferiority, randomized clinical trial enrolled patients with LARC within 6 to 12 cm from the anal verge and with negative MRI-predicted MRF. Participants were randomized to the intervention group (primary surgery, in which the patients with positive pathologic [CRM] circumferential margins were subjected to chemoradiotherapy [CRT] and those with negative CRM underwent adjuvant chemotherapy according to pathologic staging) or the control group (preoperative CRT, in which all patients underwent subsequent surgery and adjuvant chemotherapy). The primary endpoint was 3-year disease-free survival (DFS). A total of 275 patients were randomly assigned to the intervention (n = 140) and control (n = 135) groups, in which 33.57% and 28.15% patients were at clinical T4 stage and 85.92% and 80.45% patients were at "bad" or "ugly" risk in the intervention and control groups, respectively. There were 2 patients (1.52%) and 1 patient (0.77%) with positive CRM in the intervention and control groups, respectively (P > .05). The non-adherence rates for the intervention and control groups were 3.6% and 23.7%, respectively. After a median follow-up of 34.6 months (IQR, 18.2-45.7), 43 patients had positive events (28 patients and 15 patients in the intervention and control groups, respectively). There were 6 patients (4.4%) with local recurrence in the intervention group and none in the control group, which led to the termination of the trial. The 3-year DFS rate was 81.82% in the intervention group (95% CI, 78.18%-85.46%) and 85.37% in the control group (95% CI, 81.75%-88.99%), with a difference of -3.55% (95% CI, -3.71% to -3.39%; hazard ratio, 1.76; 95% CI, 0.94-3.30). In the per-protocol data set, the difference between 3-year DFS rates was -5.44% (95% CI, -5.63% to -5.25%; hazard ratio, 2.02; 95% CI, 1.01-4.06). Based on the outcomes of this trial, in patients with LARC and MRI-negative MRF, primary surgery could negatively influence their DFS rates. Therefore, primary surgery was an inferior strategy compared with preoperative CRT followed by surgery and cannot be recommended for patients with LARC.

Free-breathing three-dimensional simultaneous myocardial T1 and T2 mapping based on multi-parametric SAturation-recovery and Variable-flip-Angle

BackgroundQuantitative myocardial tissue characterization with T1 and T2 parametric mapping can provide an accurate and complete assessment of tissue abnormalities across a broad range of cardiomyopathies. However, current clinical T1 and T2 mapping tools rely predominantly on two-dimensional (2D) breath-hold sequences. Clinical adoption of three-dimensional (3D) techniques is limited by long scan duration. The aim of this study is to develop and validate a time-efficient 3D free-breathing simultaneous T1 and T2 mapping sequence using multi-parametric SAturation-recovery and Variable-flip-Angle (mSAVA). MethodsmSAVA acquires four volumes for simultaneous whole-heart T1 and T2 mapping. We validated mSAVA using simulations, phantoms, and in-vivo experiments at 3T in 11 healthy subjects and 11 patients with diverse cardiomyopathies. T1 and T2 values by mSAVA were compared with modified Look-Locker inversion recovery (MOLLI) and gradient and spin echo (GraSE), respectively. The clinical performance of mSAVA was evaluated against late gadolinium enhancement (LGE) imaging in patients. ResultsPhantom T1 and T2 by mSAVA showed a strong correlation to reference sequences (R2 = 0.98 and 0.99). In-vivo imaging with an imaging resolution of 1.5 × 1.5 × 8 mm3 could be achieved. Myocardial T1 and T2 of healthy subjects by mSAVA were 1310 ± 46 and 44.6 ± 2.0 ms, respectively, with T1 standard deviation higher than MOLLI (105 ± 12 vs 60 ± 16 ms) and T2 standard deviation lower than GraSE (4.5 ± 0.8 vs 5.5 ± 1.0 ms). mSAVA T1 and T2 maps presented consistent findings in patients undergoing LGE. Myocardial T1 and T2 of all patients by mSAVA were 1421 ± 79 and 47.2 ± 3.3 ms, respectively. ConclusionmSAVA is a fast 3D technique promising for clinical whole-heart T1 and T2 mapping.

Management of the Axilla After Neoadjuvant Chemotherapy: Can Axillary Needle Biopsy Replace Sentinel Node Biopsy?

The aim of the study was to investigate whether it is possible to evaluate the axilla after treatment without performing sentinel lymph node biopsy (SLNB) in breast cancer patients with biopsy-proven axillary lymph node metastases who received neoadjuvant chemotherapy (NAC). This prospective, randomized, clinically designed study included patients with clinical T1-3 and biopsy-proven N1 breast cancer. Prior to the surgery scheduled after NAC, the patients were randomized into two groups. A biopsy sample was obtained from the clipped axillary lymph node, which was preoperatively known to be metastatic, using fine needle aspiration (FNAB) in the first group and core needle biopsy (CNB) in the second group. The predictive ability of the two biopsy methods for the SLNB results was evaluated. The study included 50 female patients with breast cancer, with a mean age of 48.4±10.72 years. In both groups, metastasis was detected in nine patients, and no metastasis was seen in 14 patients. In intergroup comparisons, all patients with metastasis in the FNAB group also had metastasis according to SLNB, while 21.4% of the cases without metastasis in this group were metastatic according to SLNB. In the CNB group, metastasis was observed in all patients with metastasis according to SLNB, while no metastasis was detected in those who were reported to have no metastasis by SLNB. The accuracy, specificity, and sensitivity values for the prediction of SLNB results were all found to be 100% for CNB, whereas they were 87%, 100%, and 75%, respectively, for FNAB. Both CNB and FNAB could potentially replace SLNB due to their high accuracy rates in evaluating the axilla after NAC. The sensitivity and accuracy of CNB were determined to be higher.

Safety and efficacy of bronchial thermoplasty in refractory asthma with severe obstructive respiratory dysfunction.

Bronchial thermoplasty (BT) is a recently developed non-pharmacological therapy for refractory bronchial asthma. Although increasing evidence has suggested that BT is effective for various phenotypes of severe asthma, its safety and efficacy in patients with severe irreversible impaired lung function are unclear. To assess the efficacy and safety of BT in patients with refractory asthma, including patients with a severely impaired forced expiratory volume in 1 second (FEV1). This was a single-center, retrospective, observational cohort study. We retrospectively reviewed the medical records of 15 patients with refractory asthma (Global Initiative for Asthma step 4 or 5), including patients with severely impaired airflow limitation (% predicted pre-bronchodilator FEV1 <60%), who had undergone BT between June 2016 and January 2022. We analyzed the efficacy (change in asthma symptoms, exacerbation rate, pulmonary function, asthma medication, and serum inflammatory chemokine/cytokines before and after BT) and complications in all patients. We compared these data between patients with severe obstructive lung dysfunction [group 1(G1)] and patients with FEV1 ⩾ 60% [group 2 (G2)]. Six patients were in G1 and nine were in G2. Clinical characteristics, T2 inflammation, and concurrent treatment were equivalent in both groups. BT significantly improved asthma-related symptoms (measured using the Asthma Control Test and Asthma Quality of Life Questionnaire scores) in both groups. FEV1 was significantly improved in G1 but not in G2. Four patients in G2, but none in G1, experienced asthma exacerbation requiring additional systemic corticosteroids (including two requiring prolonged hospitalization) after BT. Long-term responders (patients who reduced systemic or inhaled corticosteroid without newly adding biologics in a follow-up > 2 years) of BT were identified in G1 and G2 (n = 2, 33.3% and n = 4, 44.4%, respectively). BT in patients with refractory asthma and severe airflow limitation is equally safe and efficacious as that in patients with moderate airflow limitation.

Trends and outcomes in neoadjuvant chemotherapy for clinical T1 pancreatic adenocarcinoma: should it be standard of care?

Trends and outcomes in neoadjuvant chemotherapy for clinical T1 pancreatic adenocarcinoma: should it be standard of care?

Outcomes and predictors of clinical T1 renal mass (cT1) upstaged to pathological T3a (pT3a) after partial nephrectomy: A single-center experience.

Clinical T1 (cT1) renal mass treated surgically has a good prognosis, but there is an upstaging risk that potentially threatens oncological outcomes after partial nephrectomy (PN). We aim to analyze and study the incidence, predictors, perioperative morbidity, and oncological outcomes of pT3a upstaging. A retrospective study of 313 patients who underwent PN for cT1 renal mass at a single center from a single tertiary referral center between 2000 and 2021 was done. Demographic, perioperative, pathological, and outcome variables were reviewed. We compared these parameters between upstaged and non-upstaged groups. Multivariate logistic regression analysis was used to study preoperative variables associated with upstaging. Nineteen patients were upstaged to pT3a. Making an incidence of 6.1%. Upstaged tumors were bigger (5.02 cm vs. 4.08 cm, p = 0.004), had higher clinical stage T1b (84.2 vs. 40.5%, p < 0.001), had more tumors which were central location (21 vs. 3.4%, p < 0.001), had more endophytic and mesophytic tumors (15.8 vs. 5.8% and 52.6 vs. 9.5%, p < 0.001), and had higher R.E.N.A.L Nephrometry score (8.05 vs. 6, p < 0.001). Upstaged tumors had more operative times (227 vs. 203 min, p = 0.01), more postoperative complications (68.4 vs. 13.1%, p < 0.001), more major complications of Clavien Dindo Grade 3 and above (15.8 vs. 4.4%, p < 0.001). Age (OR 1.035, p = 0.034), Radiological tumor dimension (OR 1.578, p = 0.003), Radiological or Clinical stage (T1b) (9.19, p = 0.008), Higher Nephrometry score (Intermediate and High) (OR 6.184, p = 0.004) were preoperative predictors of upstaging. Oncological outcomes were comparable. Tumor upstaging was uncommon with more perioperative morbidity. Higher age, larger tumor size, higher tumor stage, and higher nephrometry scores were preoperative predictors of upstaging.