Active clinical trials for "Breast Neoplasms"

This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.

This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).

Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function. This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.

This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.

The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.

Breast-conserving surgery (BCS) has become the standard-of-care for surgical management of the majority of women with early-stage breast cancer. Successful BCS entails excision of the tumor with an adequate amount of surrounding healthy breast parenchyma, such that negative resection margins are obtained. Despite efforts to obtain tumor-free margins, approximately 20-30% of women still require reoperation. The rationale of this study is to examine the contribution of the adjunctive use of perioperative high-resolution PET-CT specimen imaging in early-stage breast cancer to the identification of all positive resection margins during breast-conserving surgery. Histopathological findings of the breast tumor specimen are applied as the gold standard. After a successful screening phase and after informed consent is provided, the patient will enroll the study. The preparations for the BCS proceed following the routine protocol (i.e. as if the patient would not participate in the study). In addition to these standard preparations, on the day of surgery the patient will receive a study-specific injection with a low dose of a radiotracer substance (18F-FDG; 0.8 MBq/kg). Before injection, the blood sugar level will be measured by a small finger prick. If the blood sugar level is good, the radiotracer substance will be intravenously administered. The injection is given at the nuclear medicine department between 30 minutes and 3 hours before surgery. After the injection was given, the patient will be transferred to the operating theatre. The breast tumor will be removed in the same way as if the patient is not participating in the study. As soon as the tumor is excised, it will be imaged using the specimen PET-CT scanner in the operating theatre. While waiting for these 3D images, the surgeon will remove the lymph nodes, if applicable. The breast surgeon will then evaluate the 3D images of the removed breast tumor. In case of suspected positive margins, the surgeon will excise additional breast tissue to ensure that all tumor tissue is excised during this surgery. For scientific purposes only and if available, the cavity shaves and resected lymph nodes will also be imaged with the specimen PET-CT scanner. No clinical decisions that could affect further treatment will be based on this. After surgery, all excised tissues will be sent to the pathology department. This is standard routine and is also done for patients not participating in the study. A routine follow-up visit will be planned with the surgeon. During that routine visit, a staff member of the study team will ask additional study-related questions regarding possible complications. If the latter is not possible during the standard follow-up visit, a staff member of the study team will contact the patient by phone call 1-3 weeks after surgery. The study is completed after this follow-up visit or phone call.

This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.

Estrogen Receptor (ER) is a crucial prognostic factor and treatment target in breast cancer patients. Knowledge of its status greatly influences the choice of the optimal course of treatment. Pathological evaluations of primary tumor, axillary nodes, and metastases are the only confirmatory approach to ER status determination and are limited to known and accessible sites. However, it is known that many advanced breast cancer patients harbor diseases presenting inter-tumor or temporal ER heterogeneity, as ER expression can vary between tumor foci and can evolve during treatment and at time of recurrence, hence the need for whole-body, non-invasive assessment of ER status. In the last decades, 16α-[18F]fluoroestradiol (FES) was developed and evaluated as an ER-targeting positron emission tomography (PET) tracer. FES correlated with ER expression, and recently was shown to be able to predict hormone therapy response. Our Center designed and evaluated 4-fluoro-11β-methoxy-16α-[18F]fluoroestradiol (4FMFES), a successor PET tracer for ER imaging. Paired comparison during a phase II clinical trial showed that 4FMFES produced images of better quality, with less overall non-specific signal than FES. It resulted in a significantly improved tumor contrast and tumor detectability using 4FMFES-PET leading to increased diagnosis confidence in early-stage breast cancer compared to FES-PET. Those results demonstrated that, as of now, 4FMFES-PET is the best imaging modality worldwide for whole-body ER status determination, but further validations are necessary to position this method as a standard and essential tool for breast cancer management. Like what was observed for FES-PET, preliminary data suggest that 4FMFES-PET combined with FDG-PET will yield very high sensibility for breast tumor detection, each method being complementary. In continuity with previous work, we seek to expand our clinical knowledge of this high-potential diagnostic imaging through the following main objective: Launch a phase II clinical trial to explore the full potential and benefit of 4FMFES-PET in combination with FDG-PET for advanced ER+ breast cancer patients to demonstrate it is an essential tool for cancer management. This proposed project will focus on 3 specific aims: Compare and complement 4FMFES-PET with FDG-PET and conventional imaging modalities, and evaluate how they improved prognosis and staging of ER+ advanced breast cancer patients; Correlate 4FMFES/FDG uptake and staging with pathological data (histology, receptor status, grade), including distal biopsy metastases sampling; Correlate 4FMFES/FDG uptake and staging with longitudinal outcomes (treatment response, progression-free survival, time-to-relapse) to determine which cohort of patient benefit most from 4FMFES.

This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.