This phase I trial studies how well 18F-FBnTP positron emission mammography works in detecting breast cancer in patients with intraductal breast cancer. 18F-FBnTP positron emission mammography may detect may detect breast lesions with better sensitivity and better specificity.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02204462.
PRIMARY OBJECTIVES:
I. A feasibility study to assess the capacity of fluorine F 18 fluorobenzyl triphenyl phosphonium (18F-FBnTP) positron emission mammography (PEM) to detect and localize malignant breast lesions.
SECONDARY OBJECTIVES:
I. To quantify FBnTP tumor uptake and size, and tumor-to-background ratio (TBR).
II To correlate FBnTP PEM results with tumor size, grade and stage, as reported by clinical histopathology.
III. To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests including, mammogram, 18F fludeoxyglucose (18F-FDG) PEM and magnetic resonance imaging (MRI).
OUTLINE:
Patients receive 18F-FBnTP intravenously (IV) and undergo PEM scan over 90 minutes. Patients also receive 18F-FDG IV and undergo PEM scan over 90 minutes.
After completion of study, patients are followed up within 24-48 hours.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMartin Pomper
