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

NCT04727632 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: HCI140278
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Estrogen Receptor Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  12 weeks

Study Arms (1)

Treatment: all patients

EXPERIMENTAL

One session of \[18F\]FES PET/CT Imaging

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

Interventions

[18F]Fluoroestradiol (FES) PET/CT DRUG

\[18F\]Fluoroestradiol (FES) PET/CT

Treatment: all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

proto-oncogene protein c-fes-fps

Study Officials

• Matthew Covington, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a companion imaging study to IRB # 131027 FORESEE: Functional precision oncology for metastatic breast cancer: a feasibility trial. This companion imaging study will obtain \[18F\]Fluoroestradiol (FES)-PET/CT imaging of breast cancer patients refractory to all combinatorial hormonal therapies enrolled in the FORESEE trial and correlate the FES-PET/CT results with data from FORESEE including estrogen receptor (ER) status and drug profiling results from patient-derived organoid models.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 31, 2021
• Primary Completion: September 14, 2023
• Study Completion: July 30, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)