A Study to Analyze Supine Breast MRI
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
Site IRB
- Rochester, Minnesota: 18-010809
Sponsor Protocol Number: 18-010809
About this study
The purpose of this study is to characterize the changes occurring in breast tumor-associated properties/ dimensions between the prone and supine imaging positions and to develop a dataset of supine-positioned MRIs that can be translated into an operative setting for real-time visualization.
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:
- Participants must be female.
- Participants must have a pre-operative standard mammogram with or without ultrasound.
- Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma (If biopsy was done at an outside hospital, pathology will be reviewed at MCR).
- Patient must meet standard MRI guidelines and be able and willing to undergo MRI.
- Participants will be restricted to those aged ≥18 and <80 years old.
- Participants must understand the study and be willing to sign a written informed consent document.
Exclusion Criteria:
- Participants with inflammatory breast cancer.
- Participants who are pregnant and/or lactating.
- Participants who are already enrolled in a conflicting investigational trial.
- Participants with known active collagen vascular disease.
- Participants with known implantable devices or breast implants.
- Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy.
- Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI (including but not limited to renal failure).
- Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available