[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

Overview

This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.

Full Title of Study: “[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2023

Interventions

  • Drug: [18F]Fluoroestradiol (FES) PET/CT
    • [18F]Fluoroestradiol (FES) PET/CT

Arms, Groups and Cohorts

  • Experimental: Treatment: all patients
    • One session of [18F]FES PET/CT Imaging

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents
    • Time Frame: 12 weeks
    • establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials

Secondary Measures

  • Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy
    • Time Frame: 12 weeks
    • 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
  • Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models
    • Time Frame: 12 weeks
    • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Adults aged 18 years or greater. – All patients or legal guardians are willing and able to sign written informed consent and HIPAA authorization in accordance with local and institutional guidelines. – Enrolled on the FORESEE trial. – Biopsy proven estrogen receptor positive breast cancer. – Patient deemed refractory to all combinations of hormonal therapies by FORESEE trial investigators. Exclusion Criteria:

  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion. – Patients who require monitored anesthesia for PET/CT scanning. – Patients who are too claustrophobic to undergo PET/CT scanning. – Patients who are pregnant or currently breast feeding. – Any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Matthew Covington, MD, Principal Investigator, Huntsman Cancer Institute
  • Overall Contact(s)
    • Paige Nielsen, 801-585-5942, paige.nielsen@hci.utah.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.