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

Early Phase 1

Terminated

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

• Registration Number: NCT04727632
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2021-03-31
• Primary Completion: 2023-09-14
• Study Completion: 2024-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment: all patients	[18F]Fluoroestradiol (FES) PET/CT	One session of \[18F\]FES PET/CT Imaging

Primary Outcome Measures

Name	Time	Method
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	12 weeks	establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials

Secondary Outcome Measures

Name	Time	Method
Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy	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	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

Trial Locations

Locations (1)

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States