A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer (NCT00989638)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women. This would include Breast Mammography and Magnetic Resonance Imaging (MRI) examination of your breasts. The University of Chicago Department of Radiology is performing research to develop better ways of imaging the breast. The investigators would like to be able to reliably identify abnormal tissue and determine whether abnormal areas contain cancer without surgical procedures (i.e., a biopsy which involves removing breast tissue with a needle or surgical instrument). Annual mammography has already been recommended for the patient based on family history or personal history of cancer. In young women, dense breasts sometimes make it difficult to find abnormal changes on breast cancer screening (mammograms). MRI, in combination with mammography, may increase the rate of detection of early cancers. In addition, MRI can provide better images of breast tissue. The investigators hope to prove that combining multiple screening measures including biomarkers improves the chances that, if you have a small cancer or pre-cancer, it will be found early. This study will also evaluate quality of life measures during breast cancer screening and compare breast MRI and mammogram in a high-risk population. The investigators will establish a database of clinical characteristics, blood biomarkers and interventions that will be saved for future analysis and aid in the development of more effective screening in high-risk women. This research will also help us develop tools for studies in the future.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (8 items).
Location: The University of Chicago — Chicago, Illinois
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Women will be excluded if they meet one of the following:
- active cancer at the time of enrollment. A prior history of breast cancer is permitted if the subject has completed chemotherapy and is considered disease-free at the time of enrollment.
- current pregnancy or plans for pregnancy within two years of enrollment
- presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI
- breast surgery within two weeks of study entry
- previous bilateral mastectomy (prophylactic or therapeutic)
- history of kidney disease or abnormal kidney tests
- Women who test negative in a family with identifiable BRCA mutations are ineligible regardless of risk calculation
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- The University of Chicago — Chicago, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.