Fibrocystic Breast Disease

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive ER breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PETCT and PETMRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PETCT or PETMRI scans. The study focuses on comparing these two diagnostic tracers accuracy in detecting cancer lesions in ER breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

Researchers are investigating whether touch sensation can be restored to the breast after mastectomy using neural stimulation. This trial aims to gather information to guide future studies on the safety, effectiveness, and acceptability of this approach. The study focuses on women undergoing bilateral mastectomy with two-stage reconstruction for certain types of breast cancer or breast cancer risk reduction. Participants will receive a small medical device called the Bionic Breast implant, temporarily placed in one breast during the mastectomy. This device sends tiny electrical currents to nerves to create sensory stimulation in response to touch or pressure. The device will later be removed, and the study will assess the sensations produced by the stimulation. During the study, participants will complete psychophysical tasks seven months after mastectomy, implantation, and device removal to evaluate sensation and stimulation levels. Researchers will measure outcomes such as stimulation intensity, ability to distinguish different stimuli, and mapping of sensation areas. Participants will be monitored throughout for safety and adherence, with the total study duration spanning several months post-surgery.

Researchers are evaluating a new approach to eliminate minimal residual disease MRD in patients with triple negative breast cancer TNBC that remains after multiple treatments. This aggressive cancer type often leads to lethal metastatic disease within 2 years, especially in patients without a complete tumor response after initial chemotherapy. The study aims to improve survival and cure rates by addressing residual cancer cells despite surgery and chemotherapy. The study has two phases. Phase I involves patients with metastatic TNBC or hormone-resistant, HER2neu-negative breast cancer receiving escalating doses of sarilumab combined with capecitabine chemotherapy. Sarilumab is given subcutaneously every 3 weeks alongside capecitabine taken twice daily for 14 days in 21-day cycles. Phase II includes patients with stage I to III TNBC with residual disease after neoadjuvant therapy, treated with a combination of sarilumab and capecitabine compared to historical controls receiving capecitabine alone. A parallel baseline arm receives standard capecitabine alone. Blood samples and optional bone marrow samples are collected during treatment. Participants will be monitored through blood tests and other evaluations during treatment cycles lasting up to 14 weeks. Researchers will assess the maximum tolerated dose and dose-limiting toxicities in Phase I and measure changes in circulating and disseminated tumor cells in Phase II. The study does not include masking or randomization. Participants must meet specific health and organ function criteria and agree to contraception requirements if applicable. The total study duration varies by participant, with safety and response closely observed throughout.

This research evaluates a new fluorescent localization needle designed to improve the accuracy of pathological diagnosis for small breast duct micro lesions. These tiny lesions are difficult to locate precisely with current methods, risking missed diagnoses and additional surgeries. The study compares this novel device with traditional localization techniques in patients diagnosed with intraductal breast lesions who have undergone ductal excision. Participants in this retrospective study received breast ductal excision surgery using either the novel fluorescent localization needle featuring a controllable shedding quantum dot chiral nanofluorescent coating or conventional localization needles without coatings. Tissue samples from both groups were analyzed intraoperatively with frozen section analysis and postoperatively using paraffin-embedded pathological evaluation to assess diagnostic consistency. During the study, researchers analyze the concordance between intraoperative and postoperative pathological assessments to determine the clinical utility of the new fluorescent needle. The main outcome measured is the rate of agreement in pathological findings between the two sampling times. The study period covers data analysis from June to December 2025, with the overall study completion expected by May 2026. Participants are female patients aged 18 to 75 diagnosed by ductoscopy and treated with ductal excision.

This study focuses on women with breast duct lesions, including mammary tumors, nipple discharge, and breast ductal carcinoma in situ. It evaluates a new fluorescent localization needle designed with a controllable shedding quantum dot chiral nanofluorescent coating. The goal is to compare this novel device to traditional localization methods in order to improve the accuracy of pathological diagnosis for very small breast duct microlesions, which are difficult to locate precisely during surgery and pathology assessments. Participants undergo breast duct excision surgery using either the new fluorescent localization needle or a conventional localization needle without coating. This prospective, multicenter study compares how reliably rapid pathology during surgery matches postoperative pathology when using these two localization techniques. The study aims to assess if the new needle can help surgeons and pathologists better identify tiny lesions, potentially reducing missed diagnoses and additional surgeries. During the study, participants receive surgery with one of the two localization methods and have pathological assessments performed both intraoperatively and postoperatively over a 6-week period. Researchers measure how well the rapid pathology results align with the final postoperative diagnosis. The study spans from enrollment through 6 weeks after treatment, with ongoing monitoring to evaluate the clinical usefulness of the fluorescent needle. Participation involves consenting to surgery and follow-up assessments to track diagnostic agreement and outcomes.

Researchers are examining why people have different risks and outcomes for breast cancer and related breast diseases. This observational study focuses on a diverse population in South Florida, aiming to better understand both genomic and non-genomic factors that affect breast cancer risk and outcomes. The study is led by Memorial Sloan Kettering Cancer Center and includes men and women aged 18 years and older who visit breast radiology clinics for biopsy or as new breast patients. Participants will undergo blood collection at the start and during surgery when applicable, as well as tissue collection during surgery if possible. They will also complete surveys at baseline, after surgery, and at 1, 3, and 5 years of follow-up. The study involves participants with BIRADS scores from 0 to 5 and follows their clinical characteristics over up to five years. Throughout the study, participants will provide clinical information through surveys and biological samples to help researchers track their health outcomes. The main outcome measured is the clinical characteristics of participants obtained via surveys over five years. The study provides long-term monitoring of participants breast health, with no intervention treatments involved, and aims to collect comprehensive data to understand breast cancer risks better.

Researchers are studying the effects of local treatment on health and daily life in people with early-stage breast cancer in China. The focus is on those with stage I to III invasive breast cancer receiving surgery and other therapies before or after surgery. The study aims to understand both short- and long-term physical, emotional, and social effects of treatment, including tiredness, sleep problems, emotional distress, pain, and changes in heart or lung function, to improve recovery and quality of life. Participants will receive local therapy with curative intent, which may include surgery, chemotherapy, radiotherapy, endocrine therapy, or targeted therapy given before or after surgery. This observational study involves no experimental treatment. At the start, participants undergo clinical assessments, including heart and lung tests, lab work, and collection of blood and tissue samples. They also complete questionnaires about symptoms and well-being at multiple time points over five years. During the study, participants will complete surveys about their physical symptoms, emotional health, and quality of life at baseline, one week, one month, three months, six months, one year, and then annually up to five years. Researchers will monitor treatment-related toxicities and quality of life changes through these patient-reported outcomes. The study uses electronic data collection with quality checks to ensure accurate and consistent information for analysis and future research.

Researchers are evaluating a new, less invasive laboratory test to analyze DNA from nipple fluid in adults with spontaneous, single-duct, unilateral bloody or blood-tinged nipple discharge. The goal is to distinguish between benign and malignant causes of the discharge and potentially reduce unnecessary surgeries. This observational study enrolls about 30 participants who are already scheduled for standard diagnostic breast surgery at a single center. Before surgery, a small sample of nipple fluid or nipple aspirate fluid is collected along with a blood sample. The DNA in the fluid is analyzed using low-pass whole-genome sequencing and genome-wide DNA methylation profiling. These data are compared to surgical pathology results to develop a model that classifies lesions as benign or malignant. Participants receive usual care, and study results do not affect their treatment. There is no long-term follow-up required. During the study, participants undergo sample collection before surgery and standard surgical procedures. Researchers review surgical pathology reports to assess the tests accuracy, including sensitivity, specificity, and predictive values. Safety monitoring includes minimizing discomfort from fluid collection and blood draws. The total participation time covers preoperative sampling through receipt of final pathology, with technical success and sample adequacy also assessed.

Researchers are evaluating the use of the ATUSA 3D Automated Breast Ultrasound system in women who have suspicious breast findings classified as BI-RADS 4 or 5 and are referred for biopsy. This observational study aims to gather detailed breast imaging data alongside biopsy results to create a comprehensive registry. The study also follows a subset of participants receiving neoadjuvant therapy to monitor treatment response and tumor volume changes. The study uses the FDA-cleared ATUSA device, which includes a portable ultrasound scanner, a wearable positioning accessory, and software to acquire 3D breast images. Imaging with this system is performed for data collection only and does not influence clinical care, which proceeds according to standard practice. The registry collects multimodal breast images and medical record information over the study period. Participants will undergo ATUSA imaging and other breast imaging exams, with data collected from enrollment through approximately 180 days. Satisfaction questionnaires are completed on the day of ATUSA imaging. Researchers will track the number and types of imaging exams, participant and operator satisfaction, and any adverse events related to the ATUSA system. Follow-up includes monitoring for safety events for up to seven days after imaging. The total participation duration varies but includes imaging and data collection over several months.

Researchers are evaluating the use of Targeted Sentinel Node Biopsy TSNB in patients with breast cancer who have limited nodal disease and are undergoing primary surgery. The study focuses on patients with T1 or T2 tumors and biopsy-confirmed nodal metastases with up to two abnormal nodes on axillary ultrasound. The goal is to audit surgical outcomes of TSNB and compare them with outcomes from sentinel node biopsy and targeted axillary dissection after chemotherapy, assessing arm lymphoedema and disease progression over time. The intervention involves performing TSNB using either a dual- or single-tracer technique in line with protocols from the ongoing ATNEC trial. The marked biopsy-positive node and at least three nodes are removed during surgery. Node marking techniques may include clips, black dye, magnetic seeds, or reflectors, with the timing of marking either at biopsy or a separate visit. Axillary treatment after TSNB is determined by local multidisciplinary teams based on findings. Participants will be monitored for up to 60 months, with regular assessments including histology to identify nodal macrometastases, identification rates of the marked node, false negative rates of TSNB, and arm lymphoedema. Secondary outcomes include rates of axillary, regional, and local recurrence, disease-free survival, and overall survival. This long-term follow-up will help benchmark TSNB outcomes against previous trials and provide data on surgical morbidity and disease control.