Search Results within category "Women's Health"Search all categories
Suggestions within category "Women's Health"
2 Study Matches
Site for Tomosynthesis Mammographic Imaging Screening Trial (TMIST)_EA1151_PSCI 19-080
This study is being done to answer the following question: Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast? We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.
Swati Shah at email@example.com
18 year(s) or older
Inclusion Criteria:Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.
Exclusion Criteria:Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
Feasibility Study Phase C: Expansion in Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects with Breast Cancer
The main goal of standardizing the training for surgeons and clinical staff that will be participating in the anticipated pivotal study of the Lumicell Imaging System. Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer patients and to collect safety and efficacy data.
18 year(s) or older
Inclusion Criteria:Female, age of 18 years or older
Cytology confirmed primary invasive breast cancer, ductal carcinoma in situ or a combination of both
Scheduled for lumpectomy for a breast malignancy
No uncontrolled serious medical problems
Exclusion Criteria:Subjects who are pregnant at the time of breast cancer diagnosis
Uncontrolled hypertension or other uncontrolled medical problems
Patient who is sexually active and not willing to use contraception-hormonal or barrier method, or abstinence for 60 days after injection
Individuals undergoing a second lumpectomy because of previous positive margins
Subjects who have taken an investigational drug in the 30 days prior to enrollement
Cancer, Women's Health