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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Estrogen Receptor Positive Breast Cancer
• Intervention / Treatment: Drug: [18F]Fluoroestradiol (FES) PET/CT

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Matthew Covington, MD; Phone Number: 801-585-5942; Email: matthew.covington@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute at University of Utah
      • Contact: Matt Covington, MD; Phone Number: 801-585-5942; Email: matt.covington@hci.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment: all patients; One session of [18F]FES PET/CT Imaging	Drug: [18F]Fluoroestradiol (FES) PET/CT; [18F]Fluoroestradiol (FES) PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Matthew Covington, MD, Huntsman Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HCI140278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No