Radiological Benefit Research Articles

Clinical role of crosslink augmentation during short-segment posterior lumbar interbody fusion with total facetectomy: A propensity score-matched analysis

We investigated the clinical role of crosslink augmentation during PLIF with total facetectomy. We retrospectively reviewed 376 patients who underwent one- or two-segment PLIF with unilateral or bilateral total facetectomy between January 2017 and March 2022. The patients were categorized into two groups based on whether a crosslink was instrumented or not. Radiological outcome measurements included fusion status and implant failure rates on 12-month postoperative computed tomography. Patient-reported outcome measures included the Numerical Rating Scale for lower back pain, Oswestry Disability Index, and Short Form-12 Physical Component Summary scores, which were assessed preoperatively and at 12 months postoperatively. Surgery-related complications included surgical site infection, symptomatic implant failure, and epidural hematoma. Propensity score matching was performed to compare both groups after adjusting for confounding factors, including baseline and surgical procedural characteristics. A total of 200 cases were included in the propensity score calculation, and one-to-one matching was performed, resulting in 56 pairs with and without a crosslink. The fusion status (88.7 % vs. 85.5 %), screw loosening (14.3 % vs. 14.3 %), cage subsidence (17.9 % vs. 16.1 %), and cage dislodgement (5.4 % vs. 0 %) showed no significant difference between those with and without a crosslink, respectively. No significant differences were observed in the patient-reported outcomes or surgery-related complication rates between the groups. Crosslink augmentation during PLIF with total facetectomy is not recommended because it does not provide any radiological or clinical benefit and is associated with avoidable expenses.

Clinical and Radiological Benefits of Hyaluronic Acid in Periodontal Infrabony Defects: A Systematic Review and Meta-analysis

Purpose:There is no consensus on the clinical and radiological benefits of hyaluronic acid (HA) in patients with periodontitis having infrabony defects. Hence, this study examined the effects of HA in periodontitis patients with infrabony defects through a comprehensive systematic review process.Methodology:A systematic literature search was performed using PubMed/Medline, Scopus, Embase and Cochrane Library from inception to March 2022. Randomized or non-randomized clinical trials and single-arm clinical trials that assessed the clinical and radiological benefits of HA in periodontitis patients with infrabony defects with a minimum of 6 months follow-up were included in this study. Surgical regenerative therapy was considered as the comparator. The Cochrane risk of bias assessment tool and Downs and Black checklist was used for the quality assessment of randomized and non-randomized interventional studies, respectively. A subgroup and sensitivity analyses were performed to explore the heterogeneity and robustness of the findings, respectively.Results:A total of 13 out of 725 studies were included in this systematic review, of which 9 were considered for meta-analysis. The meta-analysis indicated significant benefits of HA in terms of reduction in probing pocket depth (SMD: 1.12 mm; 95% CI: 0.60-1.65; 9 studies), bone defect depth (SMD: 1.04mm; 95%CI: 0.62-1.47; 3 studies) and gain in clinical attachment level (1.04 mm; 95% CI: 0.33-2.47; 8 studies). Overall, the quality of included studies was good.Conclusion:The current evidence indicates that the administration of HA in the periodontal regenerative treatment of infrabony defects was significantly effective in increasing clinical attachment levels and reducing probing pocket and bone defect depth.

Clinical and Radiological Benefits of Hyaluronic Acid in Periodontal Infrabony Defects: A Systematic Review and Meta-analysis

Purpose: There is no consensus on the clinical and radiological benefits of hyaluronic acid (HA) in patients with periodontitis having infrabony defects. Hence, this study examined the effects of HA in periodontitis patients with infrabony defects through a comprehensive systematic review process. Methodology: A systematic literature search was performed using PubMed/Medline, Scopus, Embase and Cochrane Library from inception to March 2022. Randomized or non-randomized clinical trials and single-arm clinical trials that assessed the clinical and radiological benefits of HA in periodontitis patients with infrabony defects with a minimum of 6 months follow-up were included in this study. Surgical regenerative therapy was considered as the comparator. The Cochrane risk of bias assessment tool and Downs and Black checklist was used for the quality assessment of randomized and non-randomized interventional studies, respectively. A subgroup and sensitivity analyses were performed to explore the heterogeneity and robustness of the findings, respectively. Results: A total of 13 out of 725 studies were included in this systematic review, of which 9 were considered for meta-analysis. The meta-analysis indicated significant benefits of HA in terms of reduction in probing pocket depth (SMD: 1.12mm; 95%CI: 0.60-1.65; 9 studies), bone defect depth (SMD: 1.04mm; 95%CI: 0.62-1.47; 3 studies) and gain in clinical attachment level (SMD: 1.40 mm; 95%CI: 0.33-2.47; 8 studies). Overall, the quality of included studies was good. Conclusion: The current evidence indicates that the administration of HA in the periodontal regenerative treatment of infrabony defects was significantly effective in increasing clinical attachment levels and reducing probing pocket and bone defect depth.

Evaluation of short-term outcomes of neoadjuvant chemotherapy followed by radical cystectomy in muscle-invasive bladder cancer: a single Egyptian institution experience

Background and aimNeoadjuvant chemotherapy (NAC) before radical cystectomy (RC) became the standard of care for muscle-invasive bladder cancer (MIBC) in the last few years. We aimed to evaluate the radiological, pathological responses to NAC, and the 30-day surgical outcomes after RC in MIBC.Patients and methodsA retrospective cohort study involving adult patients with localized urothelial MIBC who received NAC followed by RC at the National Cancer Institute of Egypt (NCI-E) for 2 years (2017 and 2018). Out of 235 MIBC cases, we recognized 72 patients (30%) who fitted the eligibility criteria.ResultsA cohort of 72 patients with a median age of 60.5 years (range 34–87). Hydronephrosis, gross extravesical extension (cT3b), and radiologically negative nodes (cN0) were depicted initially in 45.8, 52.8, and 83.3% of patients, respectively. Gemcitabine and cisplatin (GC) was the rampant NAC employed in 95.8%. Radiological evaluation post NAC using RECIST v1.1 revealed a response rate (RR) of 65.3% in bladder tumor and progressive disease in the former and lymph nodes encountered in 19.4 and 13.9%, respectively. The median time from the end of NAC to surgery was 8.1 weeks (range 4–15). Open RC and ileal conduit were the most common types of surgery and urinary diversion, respectively. Pathological down-staging was encountered in 31.9%, and only 11 cases (15.3%) achieved pathological complete response (pCR). The latter was significantly correlated with the absence of hydronephrosis, low-risk tumors, and associated bilharziasis (p = 0.001, 0.029, and 0.039, respectively). By logistic regression, the high-risk category was the only independent factor associated with a poor likelihood of achieving pCR (OR 4.3; 95% CI 1.1–16.7; p = 0.038). Thirty-day mortality occurred in 5(7%) patients, and 16(22%) experienced morbidity, with intestinal leakage being the most frequent complication. cT4 was the only significant factor associated with post-RC morbidity and mortality compared to cT2 and cT3b (p = 0.01).ConclusionsOur results are further supporting the radiological and pathological benefits of NAC in MIBC, evidenced by tumor downstaging and pCR. The complication rate after RC is still considerable; hence, more larger studies are necessary to postulate a comprehensive risk assessment tool for patients who would get the maximum benefit from NAC, hoping to accomplish higher complete response rates with ultimately increased adoption of the bladder preservation strategies.

Dynamic condylar screw functional outcome in the treatment of unstable proximal femoral fractures in adult patients

Objective: The purpose of this study was to assess the functional outcome of dynamic condylar screw (DCS) fixation in the treatment of unstable proximal femoral fractures in adults. Study Place and Duration: This descriptive study was done from March 2021 to November 2022 at MTI Lady Reading Hospital Peshawar. Methods: A descriptive study, employing dynamic condylar screws to treat proximal femur fractures in all adult patients who met the inclusion criteria, was utilized in this in-depth examination (DCS). The Harris Hip Score was used to determine post-surgery mobility. Results: The average age of patients was 63 having standard deviation of 14. Fracture union took 14.3 +/- 3.8 weeks on the average. At 24 months, the typical HHS was 85.2 +/-12.3, and 78.1% of patients reported adequate or outstanding functional performance. Nonunion, malunion, or hardware failure occurred in 13.3% of patients. Complications were unaffected by age, gender, or fracture type. Conclusion: Dynamic condylar screw therapy has demonstrated promising functional and radiological benefits with few adverse effects in people with unstable proximal femoral fractures. DCS fixation, an efficient treatment for such fractures, is one of the best treatment for such fractures.

Radiological Benefits of Vitamin D Status and Supplementation in Patients with MS—A Two-Year Prospective Observational Cohort Study

Current data emphasize the immunomodulating role of vitamin D in enhancing the anti-inflammatory response. Vitamin D deficiency is an established risk factor for developing multiple sclerosis-the autoimmune demyelinating and degenerative disease of the central nervous system. Several studies confirmed that higher vitamin D serum level is associated with better clinical and radiological outcomes in patients with multiple sclerosis, whereas vitamin D supplementation benefits in multiple sclerosis remain inconclusive. Despite that, many experts suggest regular measurements of vitamin D serum levels and supplementation in patients with multiple sclerosis. In this study, 133 patients with multiple sclerosis (relapsing-remitting subtype) were prospectively observed in a 0-, 12- and 24-month time span in a clinical setting. The study group consisted of 71.4% of patients (95 out of 133) supplementing vitamin D. The associations between vitamin D serum levels, clinical outcomes (disability status expressed by EDSS, number of relapses and time to relapse) and radiological outcomes (new T2-weighted lesions and number of gadolinium-enhanced lesions) were evaluated. There were no statistically significant correlations between clinical outcomes and vitamin D serum levels or supplementations. Fewer new T2-weighted lesions were observed in patients with vitamin D supplementations (p = 0.034) in 24 months of observation. Moreover, an optimal or higher level of vitamin D (>30 ng/mL) maintained throughout the entire observation period was associated with a lower number of new T2-weighted lesions in 24 months of observation (p = 0.045). These results support vitamin D implementation commencement and amelioration in patients with multiple sclerosis.

Real-life use of trametinib after immunotherapy failure in BRAF wild-type advanced melanoma.

BRAF V600 wild-type advanced melanomas quickly reach a therapeutic dead-end, after immunotherapy failure. Even if preclinical studies have suggested sensitivity to MEK inhibitors such as trametinib in NRAS, NF1 or GNA mutated melanoma, therapeutic options are limited for these patients. We present a retrospective monocentric study of 22 patients with advanced melanoma treated by trametinib after immunotherapy resistance. Melanomas harboured NRAS (20), NF1 (1) or GNA 11 (1) mutations. For most of them (18), anti-PD1 was associated with trametinib. A disease-control was reported in 36% of patients (8/22), with six stable diseases and two partial responses according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Median progression-free survival was 2 months (1-14) and median overall survival was 6.5 months (2-24). In patients with progressive disease (14/22), dissociated radiologic responses and clinical benefits such as pain reduction were seen in five patients. High blood level of lactate dehydrogenase (LDH) seemed associated with trametinib failure, without significance ( P = 0.06). Adverse events (grade 1-3) occurred in 91% of patients during the first weeks of treatment, mainly papulo-pustular rashes (77%), leg oedemas (36%), asthenia (18%) and diarrhoea (14%). This real-life study showed that trametinib may benefit some metastatic melanoma that progressed after chemotherapy and immune checkpoint inhibitors. Objective disease control (partial response or stable disease) using RECIST criteria was observed in 36% of patients. Because of frequent side-effects which can alter the quality of life and the short response duration, this off-label option has to be discussed with the patient. Studies with combination therapy with trametinib to improve relapse-free survival and lower side-effects are ongoing.

Clinical Results After Intra-Cavitary Drainage Of Giant Bullae In Patients With Poor Pulmonary Reserves.

Giant bullae (GB) are space occupying lesions associated with chronic respiratory symptoms. The aim of this study is to evaluate outcome of intra-cavitary tube drainage procedures (ITDP) in terms of clinical and radiological benefits. A prospective study was conducted in The Department of Thoracic Surgery, Jinnah Postgraduate Medical Center, Karachi, from February 2021 to April 2022 after ethical approval. Patients above 12 years, with poor reserve and GB underwent clinical, radiological and laboratory assessment before and after ITDPs to document various studied parameters. A total of 48 patients were included; thirty-two (66.7%) were males. Mean age was 46.7±12.14 years. Most common aetiology was COPD (28; 58.3%). GB were ≥10 cm in size in 36 (75%) with right upper lobe involvement in 20 (41.7%). Preoperative dyspnoea score of IV was seen in 41 (85.4%) and chest pain in 42(87.5%) patients. In 34(70.8%) patients, Monaldi procedure and in 14 (29.2%) Brompton technique was used. Dyspnoea score improved from grade IV to II (24/41; p=0.004) along with reduction in pain and cough (p=0.012; p=0.002), respectively. Improvement post operatively in oxygen saturation, forced vital capacity, forced expiratory volume in 1 sec (6.08±1.36%, 0.73±0.516 L and 0.57±0.07 L, respectively, p<0.001) was seen. Partial pressure of oxygen (PaO2) and carbon dioxide improved by 40.6±4.82 (p=0.009) and 13.22±3.62mmHg (p=0.7). Improvement of PaO2 was associated with reduction in the size of bullae (9.33±5.13cm; p=0.006). Radiographical resolution was seen in 41 (87.5%) majorly within 2 months (21; 51.2%). Duration of hospital stay was 4.20±0.92 days with no mortality. Complications were seen in 25 (52.1%) patients. Intra-cavitary tube drainage procedures allow both clinical and physiological improvement in patients with GB. They allow resolution of bullae in patients with poor reserves and help in expansion of underlying compressed lung, improving both the clinical symptoms and radiological picture.

Freehand Pre-drilling Technique for Lateral Mass Screw Fixation Is More Efficient and Reliable Versus Sequential Drilling Technique: A Sawbone Analysis.

Background Since posterior cervical fixation with lateral mass screws was introduced in 1979, multiple techniques have been described in the literature. However, no study to date has determined whether pre-drilling all lateral masses prior to screw insertion has a benefit over the traditional sequential drilling and screw insertion on the alignment of the screw-rod construct. This study sought to determine the efficacy and efficiency in achieving alignment with a novel pre-drilling technique compared to the traditional sequential drilling technique. The authors hypothesized that the novel pre-drilling technique could be applied more quickly and precisely than the traditional sequential drilling technique. Methods Eight cervical spine sawbones models were utilized to place 64 lateral mass screws by two surgeons. The pre-drilling technique was utilized to place 32 screws in four models, and the sequential drilling technique was utilized to place the 32 screws in the remaining four models. In the traditional sequential drilling technique, each lateral mass underwent screw tract preparation and insertion before proceeding to the subsequent vertebra. In the pre-drilling technique, all lateral masses were marked and drilled sequentially before screw placement. CT imaging with 3D reconstructions was generated for all models. Variability in screw placement and time taken to fully instrument the models were compared. Results The mean time to completion of the pre-drilling technique was 337 ± 22 seconds compared to 490 ± 22 seconds with the traditional technique (p<0.01). There was a significantly higher variability in the coronal plane within the traditional group between C5 and C6 compared to other adjacent vertebrae (p<0.05). There was no significant difference in the start point variability and the overall tightness of line fit between the techniques. Conclusions Our study suggests that a novel pre-drilling technique for lateral mass screw insertion may be more efficient and reliable than the traditional sequential drilling technique. In addition, this technique may reduce the need for rod contouring or additional implants to optimize the alignment of cervical instrumentation. However, further clinical studies are necessary to validate the potential clinical and radiologic benefits of this described technique.

Comparative Analysis With Modified Inclined Technique for Posterior Endoscopic Cervical Foraminotomy in Treating Cervical Osseous Foraminal Stenosis: Radiological and Midterm Clinical Outcomes.

ObjectiveWe compared the midterm clinical and radiological outcomes between 2 types of full endoscopic posterior cervical foraminotomy, including conventional posterior endoscopic cervical foraminotomy (PECF) and modified inclined technique for PECF. MethodsOne of the 2 types of PECF surgery was performed for defined cervical foraminal stenosis. The foraminal expansion ratio and facet resection rate and foraminal stenosis grade were measured using magnetic resonance imaging. Visual analogue scale (VAS) scores for neck and arm pain, neck disability index, MacNab criteria, operation time, hospital stay, and complications, including postoperative dysesthesia, were assessed. Clinical and radiological parameters were compared between the 2 surgical groups. ResultsThere were 49 and 46 patients in the PECF and modified-PECF groups, respectively. The modified-PECF group showed significantly higher expansion of distal foraminal diameter and foraminal height, and a lower facet resection rate compared to PECF group (in all, p<0.001). The modified-PECF group displayed significantly lower VAS score for neck pain at 1 day and 1 week after surgery and lower arm pain VAS score after 6-month follow-up (p=0.002, p=0.001, p=0.002, respectively). ConclusionCompared with the PECF, the modified inclined technique has radiologic benefits, including enhanced facet joint preservation, restoration of the natural course of nerve roots, and prevention of restenosis by expanding the superior articular process base, especially in grade 2 foraminal stenosis. Furthermore, the modified inclined technique significantly improved the postoperative VAS score for neck pain within the 1-week follow-up and that of arm pain after 6-month follow-up.

The role of information display board in assessing and influencing the knowledge and perception of patients on dental radiography: an institution based prospective cohort study

Background: Patients gain knowledge about dental radiography from various sources and this can attribute to their perception and attitude. There is a broad conception that the general public have much reservation about dental radiography.Methods: 300 randomly selected samples visiting as outpatients to oral radiology of our institution were selected for the study. A pilot-tested questionnaire containing 15 questions related to evaluation of knowledge and perception of dental radiography was given to the selected samples and asked to select their choice. Then an information display board related to dental radiography and radiation protection protocols was presented. Following which the questionnaire was redistributed and the study samples were asked to alter the choices of answers, if any. The data obtained were recorded and statistical analysis was done using Shapiro-Wilk and t-test.Results: Prior exposure to information display, 50% of the participants felt that the x-radiations are harmful and 36% believed that the benefits of diagnostic radiology do not outweigh the potential risk. After the exposure to displayed board containing information regarding dental radiography, 95% acknowledged that the radiographs play a vital role in diagnosis and 85% recognized that the benefits of radiography outweigh its risk.Conclusions: The findings of the study suggests that the radiology educational display board imparted better knowledge and acceptance of dental radiology protocols among the participants.

Patient-centered Care and Integrated Practice Units: Embracing the Breast Care Continuum.

Patient-centered care is a health care approach optimized for the needs of the patient. As patients have sought more autonomy in recent years, this model has been more frequently adopted. Breast radiologists aspiring to advance patient-centered care should seek greater ownership of the breast diagnostic imaging and intervention workflows, helping their patients navigate the complex breast care landscape with patients' preferences taken into account. Applying this approach to breast radiology will increase patient satisfaction and compliance while also limiting wasted health care dollars, unnecessary diagnostic delays, and overall confusion. Herein, the benefits of patient-centered breast radiology are discussed, and numerous suggestions and case examples are provided to help readers reshape their practice toward the priorities of their patients.

Dark-field computed tomography reaches the human scale

X-ray computed tomography (CT) is one of the most commonly used three-dimensional medical imaging modalities today. It has been refined over several decades, with the most recent innovations including dual-energy and spectral photon-counting technologies. Nevertheless, it has been discovered that wave-optical contrast mechanisms-beyond the presently used X-ray attenuation-offer the potential of complementary information, particularly on otherwise unresolved tissue microstructure. One such approach is dark-field imaging, which has recently been introduced and already demonstrated significantly improved radiological benefit in small-animal models, especially for lung diseases. Until now, however, dark-field CT could not yet be translated to the human scale and has been restricted to benchtop and small-animal systems, with scan durations of several minutes or more. This is mainly because the adaption and upscaling to the mechanical complexity, speed, and size of a human CT scanner so far remained an unsolved challenge. Here, we now report the successful integration of a Talbot-Lau interferometer into a clinical CT gantry and present dark-field CT results of a human-sized anthropomorphic body phantom, reconstructed from a single rotation scan performed in 1 s. Moreover, we present our key hardware and software solutions to the previously unsolved roadblocks, which so far have kept dark-field CT from being translated from the optical bench into a rapidly rotating CT gantry, with all its associated challenges like vibrations, continuous rotation, and large field of view. This development enables clinical dark-field CT studies with human patients in the near future.

Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: Phase 2 APOLITOS study

Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, has been developed as a treatment for relapsing multiple sclerosis (RMS) which can be self-administered at home. Objective: To investigate the efficacy and safety of ofatumumab in RMS patients from Japan and Russia. Methods: APOLITOS included a 24-week, double-blind, placebo-controlled core-part followed by an open-label extension-part. Patients were randomized (2:1) to subcutaneous ofatumumab 20 mg or placebo. Primary outcome was the number of gadolinium-enhancing (Gd+) T1 lesions per scan over 24 weeks. Results: Sixty-four patients were randomized (ofatumumab, n = 43; placebo, n = 21). Primary endpoint was met; ofatumumab reduced Gd + T1 lesions versus placebo by 93.6% (p < 0.001) and the results were consistent across regions (Japan/Russia). Ofatumumab reduced annualized T2 lesion and relapse rate versus placebo by week 24. Both groups showed benefit from ofatumumab in the extension-part. Incidence of adverse events was lower with ofatumumab versus placebo (69.8% vs 81.0%); injection-related reactions were most common. No deaths, opportunistic infections, or malignancies were reported. Conclusion: Ofatumumab demonstrated superior efficacy versus placebo, with sustained effect through 48 weeks in RMS patients from Japan/Russia. Switching to ofatumumab after 24 weeks led to rapid radiological and clinical benefits. Safety findings were consistent with pivotal trials.

Efficacy of adjuvant phosphatidylcholine in the management of egyptian patients with non alcoholic fatty liver disease (NAFLD)

Background and Aim: Non-Alcoholic Fatty Liver Disease (NAFLD) has become the most common liver disorder with increased liver related and non-related complications and mortality as a result of increasing obesity, type 2 diabetes and metabolic syndrome (MetS). The current study aims to evaluate the efficacy of adjuvant phosphatidylcholine in treating patients with NAFLD. Methods: This interventional randomized controlled study recruited 100 patients with NAFLD and MetS randomized into: a control group (n=50) that received standard care of life style modifications and an intervention group (n=50) that received phosphatidylcholine (2100 gm/day) plus standard care. Both groups received health education through clinical pharmacist for achieving sustainable weight loss for 6 months. Body mass index (BMI), waist and hip circumference, liver function, lipid profile, homeostasis model of assessment-insulin resistance (HOMA-IR) score, NAFLD-fibrosis score, steatosis score and liver stiffness measurement by transient elastography were recorded at baseline, 3 and 6 months. Results: Intervention group showed significantly (p&lt;0.05) higher number with normalized; alanine aminotransferase, total cholesterol and low density lipoprotein at midpoint and endpoint, aspartate amiontransferase at midpoint and high density lipoproteins and malondaldehyde at endpoint. Intervention group showed a significantly higher participants’ number who shifted to more favorable category of NAFLD-fibrosis score (p=0.02), radiological fibrosis stage (p=0.015) at endpoint, radiological steatosis grades and HOMA-IR score at midpoint and endpoint (p&lt;0.05). Additionally, significant number of participants in intervention group (34%) lost MetS components compared to (10%) in control group at endpoint (p=0.004). Conclusion: Adjuvant phosphatidylcholine has shown laboratory, radiological and clinical benefits in the management of Egyptian patients with NAFLD and ameliorate MetS parameters.

Use of a Commercially Available Clinical Decision Support Tool to Expedite Prior Authorization in Partnership With a Private Payer.

The aim of this study was to determine if a clinical decision support (CDS) tool could be used in partnership with a private payer to successfully expedite the prior authorization process for advanced (ie, MRI, CT, PET, nuclear medicine) imaging requests. A single academic institution integrated a commercially available CDS tool utilizing the ACR Appropriateness Criteria into the ordering process for outpatient advanced imaging tests within the electronic health record. Ordering providers could elect to use the CDS tool or ignore the available technology. In partnership with a health care insurance company and a contracted radiology benefits management company, orders deemed as "usually indicated" by the CDS tool underwent expedited prior authorization in a pilot program from June 2018 to October2019. Providers used the CDS tool for 15% (1,453 of 9,640) of outpatient advanced imaging orders. Of these orders with elective CDS scores, 69% (n= 997) qualified for an expedited prior authorization process. Under specific circumstances, a commercially available CDS tool was used in partnership with a private payer and a radiology benefits management company to expedite prior authorization of outpatient advanced imaging examination orders deemed likely to be appropriate by multispecialty professional guidelines.

Kyphoplasty with intravertebral reduction devices associated with better height restoration and greater kyphosis correction than kyphoplasty with balloons

Kyphoplasty (KP) with intravertebral reduction devices (IRD) was reported to be associated with better radiological outcomes than KP with balloons (BK) for osteoporotic vertebral compression fractures (OVCFs). However, the mechanical factors that contribute to the radiological benefits of IRDs require further investigation. To probe the mechanical factors, this retrospective matched cohort study was designed, including the older patients with painful OVCFs and treated with KP. We compared the clinical and radiological outcomes between KP with an IRD and BK, where vertebral body height and kyphotic angle of the cemented vertebrae were measured pre- and postoperatively; clinical outcomes were collected by telephone interviews. The restoration and maintenance ratio suggested that IRDs were associated with favorable effects long-term wise in anterior to middle vertebral body and kyphosis than BK in patients. The gathered results concluded the radiological benefits of IRD regarding both its efficient restoration and maintenance in vertebrae.

Abstract PS11-26: A phase 1 study of D-0502, an orally bioavailable SERD, for advanced or metastatic HR-positive and HER2-negative breast cancer

Abstract Background: Targeting the estrogen receptor (ER) has proven to be one of the most successful strategies in treating HR+ (ER+ and PR+) and HER2- breast cancer. Selective estrogen receptor degraders (SERD) can be used as single agents or in combination with CDK4/6 inhibitors such as palbociclib. Fulvestrant is currently the only approved agent in its class and is limited by poor oral bioavailability necessitating monthly intramuscular injections. D-0502 is an orally bioavailable SERD with potent activity in various HR+ and HER2- breast cancer cell lines and xenograft models. Its combination with palbociclib in both MCF-7 xenograft models and ESR-1 mutated (Y537S) patient derived breast cancer xenograft models resulted in further tumor growth inhibition or regression. Drug metabolism and pharmacokinetic studies both in vitro and in vivo demonstrated that D-0502 exhibits favorable PK profiles suitable for clinical development. Methods: A first-in-human phase 1 study was conducted to evaluate D-0502 in women with advanced or metastatic HR+, HER2- breast cancer (MBC) (NCT03471663). The primary objective is to characterize the safety and tolerability of D-0502 and D-0502 in combination with palbociclib, to identify an MTD and/or RP2D. The secondary objectives are to evaluate the PK properties and the preliminary anti-tumor activities. Patients received D-0502 orally once daily in 28-day cycles. The study has completed dose escalation (phase 1a), and dose expansion and combination studies (phase 1b) are ongoing. In phase Ia, patients were enrolled and evaluated using conventional 3+3 dose-escalation to identify the MTD of D-0502 as a single agent. The phase 1b was divided into 2 stages. In Stage 1, D-0502 was evaluated with palbociclib at a dose below the MTD first before escalating to the MTD. Stage 1 also included patients in China treated at a dose below and at the MTD as single agent as well as in combination with palbociclib. Stage 2 will further evaluate the MTD for both single agent and combination of D-0502 with palbociclib. Results: At the time of this abstract submission, phase 1a dose escalation is completed, R2PD has been identified, and no DLTs were observed. PK analysis of D-0502 indicates a dose proportional increase in exposure as the dose increases, and the exposure has exceeded the potential therapeutic exposure level based on preclinical studies. The Phase Ib Stage 1 portion has also completed enrollment and the study is currently enrolling patients into phase Ib Stage 2. D-0502 as a single agent or in combination has been well tolerated with radiological tumor response and clinical benefit response (CBR) observed. Safety, PK and preliminary efficacy data will be reported at the meeting presentation. Conclusion: A first-in-human phase 1 study of D-0502 has been initiated in women with advanced or metastatic HR-positive and HER2-negative breast cancer. D-0502 has been well tolerated and achieved significant exposure and preliminary clinical activity in patients. Further results will be presented at the meeting. Citation Format: Cynthia Osborne, Donald A Richards, Sharon T Wilks, Sami Diab, Dejan Juric, Kate Lathrop, Andrea Silber, William Edenfield, Amardeep Aulakh, Ben Cho, Binghe Xu, Tao Sun, Quchang Ouyang, Yanxia Shi, Kathryn Stazzone, Zhe Shi, Ling Zhang, Yaolin Wang, Erika P Hamilton. A phase 1 study of D-0502, an orally bioavailable SERD, for advanced or metastatic HR-positive and HER2-negative breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-26.

Endoscopic Treatment of Intracranial Arachnoid Cysts: A Retrospective Analysis of a 25-Year Experience.

Since the development of neuroendoscopy, pure endoscopic fenestration for intracranial arachnoid cysts (ACs) became more and more popular and is actually preferred by many neurosurgeons. To explore their techniques and experiences with endoscopic treatment of intracranial ACs over a 25-yr period. A total of 95 endoscopic procedures in 87 patients with 88 intracranial ACs performed at the authors' departments between February 1993 and October 2018 were retrospectively analyzed. Particular respect was given to surgical technique, complications, patients' outcome, and radiological benefit in relation to cyst location. Patients' ages ranged from 23 d to 81 yr (mean: 29.9 yr). Cysts were located temporobasal (n=31; 35.2%), paraxial supratentorial (n=14; 15.9%), suprasellar/prepontine (n=14; 15.9%), quadrigeminal (n=12; 13.6%), infratentorial (n=11; 12.5%), and supratentorial intraventricular (n=6; 6.8%). Four different endoscopic techniques were applied: cystocisternostomies (n=48; 50.5%), ventriculocystostomies (n=23; 24.2%), cystoventriculostomies (n=14; 14.7%), and ventriculocystocisternostomies (n=10; 10.5%). Pure endoscopic technique was feasible in 89 of the 95 surgeries (93.7%). Clinical improvement was documented after 82 surgeries (86.3%) and radiological benefit after 62 surgeries (65.3%). Recurrences developed in 8 cases (8.4%). Overall complication rate was 21.1% (n=20), postoperative new shunt dependency was observed in 4.2% of the cases (n=4). Pure endoscopic AC fenestration is a safe, effective, and less invasive technique providing high success and low permanent complication rates. The most frequent temporobasal cysts are the most difficult to treat endoscopically. A long-term follow-up is recommended because recurrences may occur many years after first treatment.

Relationship Between the OF Classification and Radiological Outcome of Osteoporotic Vertebral Fractures After Kyphoplasty.

Study Design:Retrospective cohort study.Objectives:The OF classification is a new classification for osteoporotic vertebral fractures. The aim of this study was to clarify the relationship between preoperative OF subgroups and the postoperative outcome after kyphoplasty in patients with such fractures.Methods:Patients who underwent kyphoplasty of a single osteoporotic vertebral fracture were included and divided into groups according to the OF subgroups. Pre- and postoperative plain radiographs were analyzed in regard to the restoration of vertebral body height and local kyphotic angle (LKA). Additionally, clinical data including pre- and postoperative Visual Analogue Scale pain scores was documented. The clinical and radiological results were compared pre- and postoperatively within groups and between groups.Results:A total of 156 patients from OF subgroups 2 to 4 were included (OF 2: n = 58; OF 3: n = 36; OF 4: n = 62). Patients from all groups experienced significant pain relief postoperatively (P < .001). Patients with OF 2 fractures showed a repositioning of the vertebral body height in the anterior and middle portions (both P < .001), but no significant improvement in LKA. For OF 3 and 4 fractures, there was a significant restoration of vertebral body height (P < .001 for both) and a significant improvement of LKA (P < .001 for both). The highest average restoration was noted in the OF 4 group.Conclusions:A higher OF subgroup is related to a higher radiological benefit from kyphoplasty. This confirms that the OF classification is an appropriate tool for the preoperative assessment of osteoporotic fractures.