18F-fluoroestradiol (FES) PET/CT for Breast Cancer

September 25, 2023 updated by: Gary Ulaner, Hoag Memorial Hospital Presbyterian

18F-fluoroestradiol (FES) PET/CT Compared To Standard-of-Care Imaging In Patients With Breast Cancer

The standard of care imaging of breast cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. 18F-fluoroestradiol (FES) is a novel PET tracer designed to detect estrogen receptors, which are often expressed in breast cancers. FES PET/CT may provide improved evaluation of metastases in patients with ER-positive breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a phase II clinical trial to assess the clinical value of FES for staging and detection of disease recurrence in patients with ER-positive breast cancer, in direct comparison to the National Comprehensive Cancer Network's (NCCN) recommended standard-of-care using CT of the chest/abdomen/pelvis and bone scan [2].

Two cohorts will be evaluated:

  1. Patients with advanced local breast cancer that will undergo standard of care imaging (CT + bone scan) to evaluate for unsuspected distant metastases.
  2. Patients with suspicion for breast cancer recurrence that will undergo standard of care imaging (CT + bone scan) to evaluate for disease recurrence.

In both cohorts, FES PET/CT will be obtained, and compared with standard of care imaging. Whether on standard of care imaging or the research FES PET/CT, lesions suspicious for unsuspected distant metastases (cohort 1) or the site of disease recurrence (cohort 2) will be selected for biopsy, as is clinically standard of care to confirm disease that would alter patient management. Pathology will be used as the reference standard for confirming malignancy.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92614
        • Hoag Memorial Hospital Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female ≥ 18 years of age.
  2. Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
  3. ECOG performance status 0 to 2
  4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

  5. Either:

    1. For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
    2. For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  3. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
  4. Selective ER Modulators (SERMs) such as tamoxifen and Selective ER Degraders (SERDs) such as fulvestrant may reduce detection of ER-positive lesions by FES. Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial Staging
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive locally advanced breast cancer
Diagnostic test: 18F-fluoroestradiol PET/CT
Estrogen receptor targeted imaging
Other Names:
  • FES PET/CT
Experimental: Suspected disease recurrence
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive breast cancer and suspected disease recurrence
Diagnostic test: 18F-fluoroestradiol PET/CT
Estrogen receptor targeted imaging
Other Names:
  • FES PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of unsuspected distant metastases
Time Frame: up to 4 weeks
FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ locally advanced disease
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of suspected disease recurrence
Time Frame: up to 4 weeks
FES PET/CT will be compared against standard of care CT/bone scan for detection of unsuspected distant metastases in patients with ER+ breast cancer and suspected disease recurrence
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoag Memorial Hospital Presbyterian

Investigators

  • Principal Investigator: Gary Ulaner, MD, PhD, Hoag Family Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 15, 2023

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 182-20-CA

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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