This phase II trial compares a new imaging method for measuring estrogen receptor level (expression) in breast cancer with the standard method of measuring estrogen receptor expression by staining cancer tissue obtained from biopsy or surgery. This new method is using combined positron emission tomography/magnetic resonance imaging (PET/MRI) scans. Studying how well PET/MRI works in assessing estrogen receptor expression may help doctors to develop and implement PET/MRI for diagnosing, staging, and monitoring treatment response in patients diagnosed with estrogen receptor positive breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03703492.
PRIMARY OBJECTIVE:
I. To measure F-18 16 alpha-fluoroestradiol (18F-FES) uptake of biopsy-proven ductal carcinoma in situ (DCIS) using breast PET/MRI.
SECONDARY OBJECTIVES:
I. Determine the optimal cut-point 18F-FES uptake value for distinguishing between estrogen receptor (ER)+ and ER-negative DCIS.
II. Determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES uptake.
III. Determine the optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS.
IV. Estimate the association of quantitative 18F-FES uptake (continuous maximum standardized uptake value [SUVmax]) with research-based Oncotype DX DCIS scores (0-100).
V. Measure the upgrade rate to invasive cancer at surgical excision.
VI. To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin levels.
EXPLORATORY OBJECTIVE:
I. To correlate tumor cell density with 18F-FES uptake on PET/MRI.
OUTLINE:
Patients receive F-18 16 alpha-fluoroestradiol intravenously (IV) over 2 minutes and gadolinium IV. After 60 minutes, patients undergo PET/MRI over 30-40 minutes. Patients may optionally undergo a second PET/MRI.
After completion of study, patients are followed up for 24 hours.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorAmy Marie Fowler