This clinical trial studies the use of 18-Fluoroestradiol positron emission tomography (PET)/computed tomography (CT) in detecting estrogen receptor positive breast cancer. Diagnostic procedures, such as 18-Fluoroestradiol PET/CT may find and diagnose breast cancer, find out how far the disease has spread, and ultimately help guide treatment decision making for patients with estrogen receptor positive breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04727632.
PRIMARY OBJECTIVES:
I. To obtain F-18 16 alpha-fluoroestradiol (18F-fluoroestradiol [FES])-PET/CT imaging of breast cancer patients refractory to all combinatorial hormonal therapies and to correlate results with estrogen receptor (ER) status and drug profiling results from patient derived organoid models.
II. Evaluate the feasibility of performing 18F-fluoroestradiol (FES)-PET/CT for evaluation of estrogen receptor status in participants of the FORESEE trial. (Exploratory)
SECONDARY OBJECTIVE:
I. To assess FES-PET/CT concordance with ER status from patient derived organoid models and concordance between FES-PET/CT imaging and patient derived organoid drug profiling results for predicting response to hormonal therapies.
EXPLORATORY OBJECTIVE:
I. To assess FES-PET/CT intra-patient heterogeneous uptake, rate of uptake on patients currently on tamoxifen, fulvestrant, or other investigational Selective Estrogen Receptor Degrader (SERD) or Selective Estrogen Receptor Covalent Antagonist (SERCA), and correlation between FES-PET/CT result and progression free survival.
OUTLINE:
Patients receive 18-FES intravenously (IV) over 30 seconds, then undergo PET/CT over 61 minutes.
After completion of study, patients are followed up to 72 hours.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorMatthew Covington
