Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection...
Breast CancerCollection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.
Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast...
Ductal Carcinoma In SituInvasive Breast CancerThe primary objective of this study is to compare the diagnostic accuracy of Digital Breast Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in determining the size of breast cancer preoperatively. Secondary objectives include: Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast...
Breast CancerThe purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.
An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
Breast CancerThe following trial is designed to offer pre-approval drug access to iniparib in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3, multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol 20090301). Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Role of 3D Tomography in Breast Cancer
Breast CancerThe primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant...
Breast CancerThe purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.
PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial
Breast CancerPatients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will be randomly assigned to one of four treatment groups: I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline) II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate) III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine) IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine) The primary study outcome is pain, which will be evaluated for each study group before, and after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection and compared with that of the patient.
Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic...
Locally Advanced Breast CancerMetastatic (Stage IV) Breast Cancer1 moreThe purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and increased difficulty in eliminating the cancer. This research will help to develop better ways to treat breast cancer which could be tailored to a patient and may be adjusted to a patient's individual needs.
Setup Variation in the Supraclavicular Lymph Nodes Treatment in Breast Cancer Patients
Breast CancerThe goal of this clinical research study is to use the On Board Imager kilovoltage (OBI KV) system and cone beam computed tomography (CBCT) scanning or CT-on-rail system to look at how well a routine device called an electronic portal imaging device (EPID) can set up a patient to receive radiation therapy on the lymph nodes in the neck.
Quantitative Analysis of Outcomes in Breast Reconstruction
Breast CancerThe first objective of this study is to assess the accuracy of digital image-processing techniques to provide measurements of human breast physical dimensions. The ultimate usefulness of these techniques is to develop quantitative outcome measures of the visual appearance of breast after local treatments for breast cancer. These measures will be used to improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy and form the basis for the future development of patient decision making aids. The second objective is to evaluate the relationship between patient reported body image outcomes and measurement of human breast physical dimensions for patients with breast cancer.