This phase I trial studies a new scanner device that combines two types of imaging called breast positron emission tomography (BPET) and digital breast tomosynthesis (DPT) for imaging of a radioactive imaging drug called 18F-fluoroestradiol (FES), as a diagnostic device for imaging estrogen receptor (ER) positive breast cancers. Radioactive drugs, such as fluoroestradiol F-18, may carry radiation directly to tumor cells and not harm normal cells. The combination of using FES and the dedicated breast scanner BPET/DBT may be a better imaging tool to help diagnosis and determine the size and location of ER+ breast cancers prior to surgery or start of breast cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05659797.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Temporarily closed to accrual
Contact: Christine Edmonds
Phone: 484-678-7901
PRIMARY OBJECTIVEs:
I. To assess tumor visualization by FES-BPET/DBT, and correlate tracer uptake, as measured by standardized uptake value (SUV), with semiquantitative ER expression on immunohistochemistry (IHC).
II. To compare FES-BPET/DBT assessment of ER+ breast tumor size and extent to that of anatomic breast imaging modalities (mammography with tomosynthesis, sonography, and breast magnetic resonance imaging [MRI]).
SECONDARY OBJECTIVES:
I. To evaluate the accuracy of FES-BPET/DBT for predicting breast tumor size and extent, including centricity and focality, as well as margin status, compared to final surgical pathology among patients with newly diagnosed ER+ breast cancer.
II. To compare accuracy FES-BPET/DBT to that of whole body PET for T and N staging as determined by surgical pathology.
III. To compare FES uptake, as measured by SUV, between invasive ductal carcinoma, invasive lobular carcinoma, and ductal carcinoma in situ.
IV. To compare the study DBT to prior clinical DBT studies in terms of image quality, tumor visualization and extent.
OUTLINE:
Patients receive 18-FES intravenously (IV), then undergo BPET/DBT over 10 minutes. Patients also undergo a tissue biopsy on study.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorChristine Edmonds
