This clinical trial compares molecular breast imaging (MBI) to standard MRI scans in diagnosing women who are at high risk for developing breast cancer. MBI uses an injection of a small amount of radioactive material called technetium-99m (Tc99m) sestamibi that is taken up in tissues that are metabolically active, such as breast cancer. This material sends out gamma rays, which are then photographed by a special camera called a gamma camera. Diagnostic procedures, such as MBI, may help find and diagnose breast cancer and find out how far the disease has spread.
Additional locations may be listed on ClinicalTrials.gov for NCT05042687.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Beatriz Elena Adrada
Phone: 713-792-2709
PRIMARY OBJECTIVE:
I. To compare the diagnostic performance of molecular breast imaging (MBI) to breast magnetic resonance imaging (MRI) in women who are at high risk of developing breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MBI compared to breast MRI in women who are at high risk of developing breast cancer.
II. To assess patient preference for the two examinations by conducting a post examination survey and follow up questionnaire.
III. To assess the relationship of tumor size, histologic subtype and location of lesion with lesion conspicuity (mild, moderate, marked uptake compared to background activity) according to MBI lexicon.
OUTLINE:
Patients undergo standard of care breast MRI. Within 2 weeks of breast MRI, patients receive technetium Tc-99m sestamibi intravenously (IV) and then undergo MBI over 40 minutes. About 12 months after MBI, patients undergo standard of care imaging.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBeatriz Elena Adrada
