Women Undergoing Breast Biopsy Research Articles

Prospective assessment of adjunctive ultrasound-guided diffuse optical tomography in women undergoing breast biopsy: Impact on BI-RADS assessments

PurposeTo assess the impact of adjunctive ultrasound guided diffuse optical tomography (US-guided DOT) on BI-RADS assessment in women undergoing US-guided breast biopsy. MethodThis prospective study enrolled women referred for US-guided breast biopsy between 3/5/2019 and 3/19/2020. Participants underwent US-guided DOT immediately before biopsy. The US-guided DOT acquisition generated average maximum total hemoglobin (HbT) spatial maps and quantitative HbT values. Four radiologists blinded to histopathology assessed conventional imaging (CI) to assign a CI BI-RADS assessment and then integrated DOT information in assigning a CI&DOT BI-RADS assessment. HbT was compared between benign and malignant lesions using an ANOVA test and Tukey’s test. Benign biopsies were tabulated, deeming BI-RADS ≥ 4A as positive. Reader agreement was assessed. ResultsAmong 61 included women (mean age 48 years), biopsy demonstrated 15 (24.6%) malignant and 46 (75.4%) benign lesions. Mean HbT was 55.3 ± 22.6 µM in benign lesions versus 85.4 ± 15.6 µM in cancers (p < .001). HbT threshold of 78.5 µM achieved sensitivity 80% (12/15) and specificity 89% (41/46) for malignancy. Across readers and patients, 197 pairs of CI BI-RADS and CI&DOT BI-RADS assessments were assigned. Adjunctive US-guided DOT achieved a net decrease in 23.5% (31/132) of suspicious (CI BI-RADS ≥ 4A) assessments of benign lesions (34 correct downgrades and 3 incorrect upgrades). 38.3% (31/81) of 4A assessments were appropriately downgraded. No cancer was downgraded to a non-actionable assessment. Interreader agreement analysis demonstrated kappa = 0.48–0.53 for CI BI-RADS and kappa = 0.28–0.44 for CI&DOT BI-RADS. ConclusionsIntegration of US-guided DOT information achieved a 23.5% reduction in suspicious BI-RADS assessments for benign lesions. Larger studies are warranted, with attention to improved reader agreement.

Relationship of Serum Progesterone and Progesterone Metabolites with Mammographic Breast Density and Terminal Ductal Lobular Unit Involution among Women Undergoing Diagnostic Breast Biopsy.

The association of progesterone/progesterone metabolites with elevated mammographic breast density (MBD) and delayed age-related terminal duct lobular unit (TDLU) involution, strong breast cancer risk factors, has received limited attention. Using a reliable liquid chromatography-tandem mass-spectrometry assay, we quantified serum progesterone/progesterone metabolites and explored cross-sectional relationships with MBD and TDLU involution among women, ages 40–65, undergoing diagnostic breast biopsy. Quantitative MBD measures were estimated in pre-biopsy digital mammograms. TDLU involution was quantified in diagnostic biopsies. Adjusted partial correlations and trends across MBD/TDLU categories were calculated. Pregnenolone was positively associated with percent MBD-area (MBD-A, rho: 0.30; p-trend = 0.01) among premenopausal luteal phase women. Progesterone tended to be positively associated with percent MBD-A among luteal phase (rho: 0.26; p-trend = 0.07) and postmenopausal (rho: 0.17; p-trend = 0.04) women. Consistent with experimental data, implicating an elevated 5α-pregnanes/3α-dihydroprogesterone (5αP/3αHP) metabolite ratio in breast cancer, higher 5αP/3αHP was associated with elevated percent MBD-A among luteal phase (rho: 0.29; p-trend = 0.08), but not postmenopausal women. This exploratory analysis provided some evidence that endogenous progesterone and progesterone metabolites might be correlated with MBD, a strong breast cancer risk factor, in both pre- and postmenopausal women undergoing breast biopsy. Additional studies are needed to understand the role of progesterone/progesterone metabolites in breast tissue composition and breast cancer risk.

Circulating cell-free DNA (cfDNA) levels in BRCA1 and BRCA2 mutation carriers: A preliminary study.

Female carriers of BRCA1 or BRCA2 germline mutations are at a substantially increased risk for developing breast and ovarian cancer. The lack of effective early detection schemes for ovarian cancer, mandate surgical removal of adnexa at age 35-40 years in these high-risk women. The role of circulating cell-free DNA (cfDNA) levels as a marker for early detection in high-risk women has rarely been reported. To quantify cfDNA levels in BRCA1BRCA2 carriers. Serum cfDNA levels, measured by direct fluorometric assay in cancer-free female BRCA1BRCA2 mutation carriers were compared with cancer-free controls recruited from among women undergoing breast biopsy or routine colonoscopy. Overall, 10 BRCA1 (185delAG) and 10 BRCA2 (6174delT) mutation carriers, 20 breast biopsy controls, and 20 colonoscopy controls participated. cfDNA levels [Median (95% CI)], were 472 (317-589) ng/ml and 525 (339-621) ng/ml in breast biopsy and colonoscopy controls, respectively. Median levels of cfDNA in BRCA1 and BRCA2 mutation carriers combined were 921 (835-1087) ng/ml, significantly higher than in both controls (P< 0.0001). cfDNA levels are significantly higher in BRCA1 and BRCA2 mutation carriers compared with non-carriers. This finding, if validated, may facilitate development of early detection breast/ovarian cancer biomarker in high-risk women.

Sveva: development and evaluation of a supportive care model to reduce breast biopsy pre-operative anxiety: a randomized case-control study

In order to assess the efficacy of the Supportive Care intervention used to reduce Pre-Operative Anxiety, a randomized case-control study has been performed at the Breast Unit of the Careggi Hospital in Florence, comparing a Supportive Care Group (taking part in a colloquium) to a Control Group receiving standard care. Interventions’ efficacy was tested in 2 ANCOVAs and in a 2-ways ANOVA. Women recruited from January 2015 to February 2015 completed: The Amsterdam Preoperative Anxiety and Information (Moreman et al., 1996), State-Trait Anxiety Inventory (Spielberg, 1983) and the The Mini - Module Depression (Sheehan, et al. 1998). In the first ANCOVA, Group produced a significant reduction of APAIS (p 0.05) (R 2 =0.11). In the third 2-Ways ANOVA: Group x Depression over Pre-Operative Anxiety, Group was significant (p<0.01), (R 2 =0.10). In our experimental design, a Supportive Care colloquium was found to significantly reduce the level of Pre-Operative Anxiety in women undergoing Breast Biopsy when compared to Standard Care, even when the confounding effect of Trait Anxiety, Age and Depression were included in the models.

Construct validity of the Amsterdam Preoperative Anxiety and Information Scale (Italian Version) in women undergoing breast biopsy: a brief research report.

The goal of this paper was to test Construct Validity of the Amsterdam Preoperative Anxiety and Information Scale (Italian Version) in women undergoing Breast Biopsy. To answer this purpose we have utilized Exploratory Factor Analysis (EFA) in a sample of 80 women undergoing Breast Biopsy at the Breast Unit of the Careggi University Hospital in Florence from January to February 2015. Overall the results support the construct validity of the Italian version of the APAIS for the population of women undergoing Breast Biopsy suggesting that the Italian version of APAIS can be useful to detect this clinically very relevant dimension. (www.actabiomedica.it)

A Randomized Controlled Trial Provides Evidence to Support Aromatherapy to Minimize Anxiety in Women Undergoing Breast Biopsy.

Aromatherapy has been used to reduce anxiety in a variety of settings, but usefulness associated with breast biopsies has not been documented. This study was conducted in women undergoing image-guided breast biopsy. We explored the use of two different aromatherapy scents, compared to placebo, aimed at reducing anxiety with the intent of generating new knowledge. This was a randomized, placebo-controlled study of two different types of external aromatherapy tabs (lavender-sandalwood and orange-peppermint) compared with a matched placebo-control delivery system. Anxiety was self-reported before and after undergoing a breast biopsy using the Spielberger State Anxiety Inventory Scale. Eighty-seven women participated in this study. There was a statistically significant reduction in self-reported anxiety with the use of the lavender-sandalwood aromatherapy tab compared with the placebo group (p = .032). Aromatherapy tabs reduced anxiety during image-guided breast biopsy. The completion of the biopsy provided some relief from anxiety in all groups. The use of aromatherapy tabs offers an evidence-based nursing intervention to improve adaptation and reduce anxiety for women undergoing breast biopsy. Lavender-sandalwood aromatherapy reduced anxiety and promoted adaptation more than orange-peppermint aromatherapy or placebo.

Effect of nurse navigation on patient care satisfaction and distress associated with breast biopsy.

Navigation during the biopsy period is a superior approach to delivering care, with those patients receiving services experiencing less distress. Critical nurse navigator roles include providing information and facilitating access to the healthcare system, both of which are influential on distress. The information in this article supports the expansion of navigation programs to include women undergoing biopsy and aids in promoting a higher standard of care. To evaluate the effect of navigation on care satisfaction and distress in women undergoing breast biopsy. A descriptive, cross-sectional survey design from two outpatient radiology clinics in Appalachia was used. Navigated women had lower scores on every distress measure and were less likely to seek information from an outside source. Women who were more satisfied with their care reported decreased distress; the factors influencing distress varied depending on whether they were the recipient of navigation services. In the non-navigated population, general satisfaction with care and accessibility were more likely to influence distress.

Comparison of mammographic density assessed as volumes and areas among women undergoing diagnostic image-guided breast biopsy.

Mammographic density (MD), the area of non-fatty-appearing tissue divided by total breast area, is a strong breast cancer risk factor. Most MD analyses have used visual categorizations or computer-assisted quantification, which ignore breast thickness. We explored MD volume and area, using a volumetric approach previously validated as predictive of breast cancer risk, in relation to risk factors among women undergoing breast biopsy. Among 413 primarily white women, ages 40 to 65 years, undergoing diagnostic breast biopsies between 2007 and 2010 at an academic facility in Vermont, MD volume (cm(3)) was quantified in craniocaudal views of the breast contralateral to the biopsy target using a density phantom, whereas MD area (cm(2)) was measured on the same digital mammograms using thresholding software. Risk factor associations with continuous MD measurements were evaluated using linear regression. Percent MD volume and area were correlated (r = 0.81) and strongly and inversely associated with age, body mass index (BMI), and menopause. Both measures were inversely associated with smoking and positively associated with breast biopsy history. Absolute MD measures were correlated (r = 0.46) and inversely related to age and menopause. Whereas absolute dense area was inversely associated with BMI, absolute dense volume was positively associated. Volume and area MD measures exhibit some overlap in risk factor associations, but divergence as well, particularly for BMI. Findings suggest that volume and area density measures differ in subsets of women; notably, among obese women, absolute density was higher with volumetric methods, suggesting that breast cancer risk assessments may vary for these techniques.

A relaxation response training for women undergoing breast biopsy: Exploring integrated care

BackgroundRecent changes in clinical guideline recommendations for age of breast cancer screening initiation highlighted the potential psychological ramifications associated with screening. This study examined the feasibility, acceptability, and preliminary efficacy of a brief Relaxation Response training (RRT) to decrease distress among women undergoing breast biopsy. MethodsWomen scheduled for percutaneous core-needle biopsy were recruited into a single-arm RRT trial, including 3 individual sessions. Psychosocial assessments were completed pre- and postintervention. ResultsForty women were enrolled between 6/1/10 and 8/31/11. Among enrollees, 75% completed all 3 RRT sessions, and 75% completed the post-assessment. Participants showed significant reductions in acute distress following each RRT session. Qualitative feedback indicated a positive impact of RRT on clinic care experiences. ConclusionsRRT is a portable intervention that was feasible to implement, acceptable to patients and associated with significant decreases in acute emotional distress during the period of diagnostic uncertainty related to percutaneous breast biopsy.

Symptom Distress Associated with Biopsy in Women with Suspect Breast Lesions

Purpose. To investigate symptom distress, quality of life, affective states, and inflammatory biomarkers before and after breast biopsy in women undergoing breast biopsy. Methods. A convenience sample of 47 women undergoing breast biopsy was assessed at the pre- and post-biopsy visits. The assessments included evaluation of fatigue, anxiety, depression, sleep disturbances, positive and negative affect, quality of life using validated self report measures, and a blood draw to determine markers of inflammation. Results. At the postbiopsy visit, a total of 15 participants were diagnosed with breast cancer, and 32 participants received negative biopsy result. The mean anxiety and sleep disturbances scores were in the clinically significant range for the total sample and for the biopsy positive (BC+) and biopsy negative (BC−) subgroups at both time points. For both subgroups, anxiety and sleep disturbances scores did not change significantly from pre- to post-biopsy. A subpopulation of participants in both groups reported moderate-to-severe anxiety, depression and fatigue levels at both time points. The inflammatory markers did not show consistent associations with psychosocial symptoms. Conclusions. A subset of participants in BC+ and BC− subgroups experience heightened symptom distress and negative impact on quality of life at both pre- and post-biopsy time points.

TU-E-217BCD-03: Characterization of Anatomical Noise in Mammography, Tomosynthesis and Breast CT.

The role of breast density in cancer detection has been well characterized, and newer modalities such as breast tomosynthesis and breast CT (bCT) were developed to improve cancer detection in the dense breast by reducing anatomical complexity. Anatomical noise was characterized on a small cohort of patient images and compared across digital mammography, tomosynthesis, and bCT images. An IRB-approved and HIPPA-compliant clinical study was performed on women undergoing breast biopsy, and mammography, tomosynthesis, and bCT were performed on both breasts immediately prior to biopsy. A total of 23 women participated in this study, and the unaffected breast (no lesion) was evaluated. A total of 1000 regions of interest were sampled on each image data set, and the 2D noise power spectrum (NPS) was evaluated. This was radially averaged to produce a 1D NPS, and the NPS was fit to a power law: ln{NPS(f)} = alpha+betaxln(f), over an anatomically-relevant range of spatial frequencies. The slope, beta, was averaged across patients and compared between modalities and projections. The value of beta was determined for bCT data sets, and they were 1.75 (0.424), 1.83 (0.352), and 1.79 (0.397), for the coronal, sagittal and axial views, respectively. For tomosynthesis, beta was 3.06 (0.361) and 3.10 (0.315) for the CC and MLO views, respectively. For mammography, these values were 3.17 (0.226) and 3.30 (0.236), for the CC and MLO views, respectively. The values of beta for breast CT were significantly different than those for tomosynthesis and mammography (p<0.001, all 12 comparisons). The results of this investigation demonstrate that the anatomical complexity of the breast, as characterized by the parameter beta, is statistically similar between mammography and tomosynthesis, a somewhat surprising finding. The breast CT image data, however, demonstrate a statistically-significant reduction in beta across all projections. Funded in part by Hologic Corporation and by a grant from the National Institute of Biomedical Imaging and Bioengineering, EB002138.

O-83 Digital infrared imaging for breast cancer detection in younger women undergoing breast biopsy

O-83 Digital infrared imaging for breast cancer detection in younger women undergoing breast biopsy

The accuracy of digital infrared imaging for breast cancer detection in women undergoing breast biopsy

Background Mammography has a lower sensitivity for breast cancer detection in younger women and those with dense breasts. Recent improvements in digital infrared breast imaging suggest there may be a role for this technology and we have studied its performance in 100 women prior to breast needle core biopsy (CB). Methods All patients were imaged using a digital infrared breast (DIB) scan (Sentinel BreastScan™) prior to breast biopsy. Analysis of the infrared scans was performed, blinded to biopsy results, in four different ways: Sentinel screening report, Sentinel artificial intelligence (neural network), expert manual review and NoTouch BreastScan a novel artificial intelligence programme. Results Of 106 biopsies performed in 100 women, 65 were malignant and 41 were benign. Sensitivity of Sentinel screening (53%) and Sentinel neural network (48%) was low but analysis with NoTouch software (70%) was much closer to expert manual review (78%). Sensitivity (78%) and specificity (75%) using NoTouch BreastScan were higher in women under 50 and the combination of mammography and DIB, with NoTouch interpretation, in this age group resulted in a sensitivity of 89%. Conclusion DIB using NoTouch is an effective adjunctive test for breast cancer detection in women under 70 and appears to be particularly effective in women under 50 where maximal sensitivity (78%) and specificity (75%) were observed. The combined sensitivity of NoTouch BreastScan and mammography in women under 50 was encouraging at 89%, suggesting a potential way forward for a dual imaging approach in this younger age group.

High Sensitivity and Specificity of Digital Infrared Imaging for Breast Cancer Detection in Younger Women Undergoing Breast Biopsy.

Abstract Background and aim: Recent published evidence suggests that digital infrared breast scanning may be a useful adjunctive tool for breast cancer detection. In this study we have assessed the effectiveness of digital infrared imaging captured using Sentinel BreastScan (Infrared Sciences Corp., Bohemia, NY, USA) and compared the computer-generated reports from this system with expert manual review of the images as well as a new software programme currently under development called NoTouch BreastScan.Methods: A total of 100 patients scheduled for breast biopsy (n=106), following detection of an abnormality via clinical examination or breast imaging were recruited to this research ethics committee-approved study. After obtaining informed consent all patients were imaged using Sentinel BreastScan, prior to their scheduled biopsy procedure in the Cambridge Breast Unit. The data for each patient was analysed in four different ways for comparison with final pathology findings as follows: 1. Sentinel screening report (score 0 = normal, 1-5 = abnormal); 2.Sentinel neural network (positive or negative); 3. Independent expert review (positive or negative); 4. NoTouch BreastScan artificial intelligence (score 0-3 = normal, 4-10 abnormal).Results: Sensitivity for the whole group using Sentinel screening (53%) and neural network (48%) was low compared to recently published data (97%), expert review (78%) and NoTouch (70%).Sensitivity and specificity results for NoTouch BreastScan by age group are shown in table1Sensitivity and specificity results for NoTouch BreastScan by age group &amp;lt;50 years, n=2150-70 years, n=73&amp;gt;70 years, n=12All patients, n=106Sensitivity78%72%42%70%Specificity75%37%N/A48% Conclusion: This study confirms acceptable sensitivity (72%) for breast cancer detection using NoTouch BreastScan in women under 70 years of age despite the data being captured with Sentinel. This sensitivity increases to 78% for women &amp;lt;50 years old and is combined with a marked increase in specificity (75%) in this group. These encouraging figures may increase even further when data is captured by the NoTouch software and studies are ongoing with this novel imaging system. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5025.

Systematic Review: Comparative Effectiveness of Core-Needle and Open Surgical Biopsy to Diagnose Breast Lesions

Most women undergoing breast biopsy are found not to have cancer. To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer. Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009. Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up. Data were abstracted by 1 of 3 researchers and verified by the primary investigator. 33 studies of stereotactic automated gun biopsy; 22 studies of stereotactic-guided, vacuum-assisted biopsy; 16 studies of ultrasonography-guided, automated gun biopsy; 7 studies of ultrasonography-guided, vacuum-assisted biopsy; and 5 studies of freehand automated gun biopsy met the inclusion criteria. Low-strength evidence showed that core-needle biopsies conducted under stereotactic guidance with vacuum assistance distinguished between malignant and benign lesions with an accuracy similar to that of open surgical biopsy. Ultrasonography-guided biopsies were also very accurate. The risk for severe complications is lower with core-needle biopsy than with open surgical procedures (<1% vs. 2% to 10%). Moderate-strength evidence showed that women in whom breast cancer was initially diagnosed by core-needle biopsy were more likely than women with cancer initially diagnosed by open surgical biopsy to be treated with a single surgical procedure (random-effects odds ratio, 13.7 [95% CI, 5.5 to 34.6]). The strength of evidence was rated low for accuracy outcomes because the studies did not report important details required to assess the risk for bias. Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates. Agency for Healthcare Research and Quality.

Effects of reiki in clinical practice: a systematic review of randomised clinical trials

The aim of this systematic review is to summarise and critically evaluate the evidence for the effectiveness of reiki. We searched the literature using 23 databases from their respective inceptions through to November 2007 (search again 23 January 2008) without language restrictions. Methodological quality was assessed using the Jadad score. The searches identified 205 potentially relevant studies. Nine randomised clinical trials (RCTs) met our inclusion criteria. Two RCTs suggested beneficial effects of reiki compared with sham control on depression, while one RCT did not report intergroup differences. For pain and anxiety, one RCT showed intergroup differences compared with sham control. For stress and hopelessness a further RCT reported effects of reiki and distant reiki compared with distant sham control. For functional recovery after ischaemic stroke there were no intergroup differences compared with sham. There was also no difference for anxiety between groups of pregnant women undergoing amniocentesis. For diabetic neuropathy there were no effects of reiki on pain. A further RCT failed to show the effects of reiki for anxiety and depression in women undergoing breast biopsy compared with conventional care. In total, the trial data for any one condition are scarce and independent replications are not available for each condition. Most trials suffered from methodological flaws such as small sample size, inadequate study design and poor reporting. In conclusion, the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.

Breast Biopsy and Distress

The purpose of this randomized pilot was to determine feasibility of testing Reiki, a complementary therapy intervention, for women undergoing breast biopsy (BB). Increasingly women face the possibility of BB, the definitive test for breast cancer. Psychological distress associated with BB includes anxiety and depression. Reiki was proposed as an intervention to decrease anxiety and promote relaxation. Thirty-two women scheduled for BB were randomized to Reiki intervention versus conventional care control. Anxiety and depression were evaluated using self-report questionnaires. Analysis found no significant mean differences between groups over time. Comparably low baseline anxiety levels (possible selection bias) decreased naturally with time allowing little room for observing treatment effect. Reiki, when administered in the naturalistic setting of a complementary therapy office, did not suggest evidence of efficacy. An intervention offered within the bounds of the conventional care setting may be more feasible for addressing BB distress.

Pain in different methods of breast biopsy: Emphasis on vacuum-assisted breast biopsy

This study examines pain (visual analog scale 0–10) in women undergoing breast biopsy. Two hundred and twenty-seven patients with a palpable lesion underwent FNA (21 G, n=85), core biopsy (14 G, n=86) or open biopsy under local anesthesia ( n=56). One hundred and twenty-six women presented with a non-palpable lesion, and underwent vacuum-assisted breast biopsy (VABB, 11 G) under mammographic guidance, prone position ( n=72) or hook-wire localization followed by open surgery ( n=54). The techniques sampling non-palpable lesions were the most painful: hook-wire (9.15±0.74) and VABB (4.35±1.70). Larger needle diameter was associated with more intense pain. Concerning VABB, an S-shape curve of pain (third-order pattern) was documented. A second dose of lidocaine just before the rapid increase phase was then adopted ( n=61), and reduced the total/maximum pain. In conclusion, although VABB is less painful than hook-wire, the pain experienced in VABB is significant; however, it can be attenuated by a second dose of lidocaine.

Predicting Biopsy Outcome After Mammography: What Is the Likelihood the Patient Has Invasive or In Situ Breast Cancer?

As many as 1,000,000 breast biopsies are performed annually in the United States. Although substantial effort has been devoted to estimating breast cancer risk, there have been no studies to predict outcome in women undergoing breast biopsy. A population-based study was undertaken to develop and test models for predicting the probability of invasive breast cancer and/or ductal carcinoma-in-situ in 7670 women undergoing breast biopsy after mammography. Logistical prediction models were developed by using data from 6129 randomly selected women and tested with data from the remaining women. The overall cancer prevalence among women undergoing biopsy was 22.4%. Prevalence in women with mammograms highly suggestive of malignancy (category 5) was 84.6%, with minimal variation in individual cancer probabilities due to age. A total of 24.6% of women with suspicious mammograms (category 4) had cancer, but individual probability estimates ranged from .01 to .86, depending on age, presence of a lump, previous biopsy, menopausal status, and use of postmenopausal hormone therapy. These variables also influenced biopsy outcome in women with other mammography assessments (categories 0-3), but the overall prevalence was lower (8.6%), and estimated probabilities ranged from .01 to .45. When cancer was present, the probability of invasive disease was influenced by mammogram assessment category, absence of mammogram calcifications, and presence of a lump. The probabilities of invasive cancer and ductal carcinoma-in-situ in women undergoing biopsy can be more accurately predicted by using clinical characteristics in addition to mammography findings. This information could potentially influence decisions regarding immediate biopsy or continued surveillance.

The NASA Smart Probe Project for Real-Time Multiple Microsensor Tissue Recognition

Background: Remote surgery requires automated sensors, effectors and sensor-effector communication. The NASA Smart Probe Project has focused on the sensor aspect. Methods: The NASA Smart Probe uses neural networks and data from multiple microsensors for a unique tissue signature in real time. Animal and human trials use several probe configurations: (1) 8-microsensor probe (2.5 mm in diameter) for rodent studies (normal and subcutaneous mammary tumor tissues), and (2) 21-gauge needle probe with 3 spectroscopic fibers and an impedance microelectrode for breast cancer diagnosis in humans. Multisensor data are collected in real time (update 100 times/s) using PCs. Results: Human data (collected by NASA licensee BioLuminate) from 15 women undergoing breast biopsy distinguished normal tissue from both benign tumors and breast carcinoma. Tumor margins and necrosis are rapidly detected. Conclusion: Real-time tissue identification is achievable. Potential applications, including probes incorporating nanoelectrode arrays, are presented.