A Study of BI-RADS 4 and 5 Lesions that are Malignant and Increased Stiffness on MR Elastography Compared to Lesions that are Benign
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Sponsor Protocol Number: 17-009720
About this study
The purpose of this study is to gather measurements of mechanical properties of BI-RADS 4 and 5 lesions in order to test the effectiveness of MR elastography (MRE) in differentiating benign versus malignant disease. We will also test the mechanical properties of bilateral breast tissue on MRE to find any correlation with breast density on mammograms.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- BI-RADS 4 or 5 lesion greater than 1cm on ultrasound.
- Female patients older than 18 years.
Exclusion Criteria:
- Pregnant and lactating females will be excluded (Women of child bearing potential will have a urine pregnancy test administered prior to the MR elastography exam).
- Patients with implanted devices including aneurysm clips, pacemakers, coils, filters, and electronic pumps will be excluded.
- Patients under the age of 18 will be excluded. Patient without decision making capacity will be excluded.
More information
Publications
Publications are currently not available