This clinical trial tests whether a supine breast magnetic resonance imaging (MRI) scan with a second dose of gadolinium-based contrast agent after a standard prone breast MRI scan will make breast tumors easier to see in supine images. Standard MRI scans of the breast are done in the prone position (lying on the stomach). When patients have surgery to remove a tumor from their breast, they are in the supine position (lying on their back). This means that the tumor may be in a different position during surgery than it is in the MRI scans. Gadolinium is a contrast agent, which helps show abnormal tissue in the body during imaging. Obtaining additional MRI scans completed in the supine position may help guide surgeons in the removal of breast tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT05131607.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the tumor to fibroglandular contrast in a two bolus prone to supine breast MRI study and compare this to the tumor to fibroglandular contrast of a single-contrast supine MRI.
SECONDARY OBJECTIVES:
I. Determine the proportion of tumors which can be successfully segmented on supine MRI imaging when the supine MRI is obtained immediately after a contrast enhanced diagnostic prone MRI, using a second contrast injection.
II. Compare the proportion of cases with successful agreement between radiologists’ segmentations (Hausdorff Distance [HD] < 1 cm) in this study to a control cohort consisting of patients who had a single-contrast supine MRI.
III. Compare the proportion of cases with successful agreement between radiologists’ segmentations (HD < 1 cm) in this study to patients in the prone to supine breast MRI trial (P2S1) study.
IV. Determine the time required to obtain the additional supine sequences.
V. Evaluate associations between intra-observer HD distances and measured tumor-to-fibroglandular contrast in each case.
VI. Evaluate whether supine Diffusion Weighted Images aid in segmenting tumors.
OUTLINE:
Patients receive gadolinium meglumine intravenously (IV) and undergo standard MRI lying in the prone position. Patients will then receive another dose of gadolinium meglumine (IV), be re-positioned into the supine position, and undergo additional MRI scans on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorRoberta diFlorio-Alexander
