Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy

NCT04692103 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: RG100783410465
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies use of F-18 16 alpha-fluoroestradiol (\[F-18\] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

Conditions

Estrogen Receptor Positive; Primary or Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (3)

• Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax

  FES uptake will be quantified using lean body mass adjusted SUV (SUL). Percentage change in FES average SULmax between baseline and a second FES scan will be calculated for up to 3 lesions per patient.

  From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)

• F-18 16 Alpha-fluoroestradiol (FES) Uptake

  Quantitative measures of FES uptake for each disease site will be determined by drawing regions-of-interest on lesions to determine maximal FES uptake (SUVmax) per lesion. Up to 10 sites seen on the static torso survey will be quantified.

  From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)

• Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)

  The number of patients showing a 20% increase in FES uptake (SULmean or SUVmax) compared to baseline from the first to second scan using a 90% Wilson score binomial confidence interval.

  From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)

Secondary Outcomes (1)

• Time to Disease Progression

  From start of therapy up to 20 years

Study Arms (1)

Diagnostic (F-18 FES PET/CT)

EXPERIMENTAL

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

Drug: F-18 16 Alpha-Fluoroestradiol; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Drug: Fludeoxyglucose F-18; Other: Laboratory Biomarker Analysis

Interventions

F-18 16 Alpha-Fluoroestradiol DRUG

Undergo F-18 FES PET/CT

Also known as: F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol, Fluoroestradiol F-18

Diagnostic (F-18 FES PET/CT)

Positron Emission Tomography PROCEDURE

Undergo F-18 FES PET/CT

Also known as: Medical Imaging, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography

Diagnostic (F-18 FES PET/CT)

Computed Tomography PROCEDURE

Undergo F-18 FES PET/CT

Also known as: CAT Scan, Computerized Axial Tomography, CT scan

Diagnostic (F-18 FES PET/CT)

Fludeoxyglucose F-18 DRUG

Undergo FDG PET/CT

Also known as: FDG, Fluorodeoxyglucose F18, 18FDG

Diagnostic (F-18 FES PET/CT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (F-18 FES PET/CT)

Eligibility Criteria

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

You may qualify if:

• Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
• Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease.
• At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging.
• Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES.
• Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented.
• Patients must be willing to undergo serial imaging procedures.
• Patients must agree to allow access to clinical records regarding response to treatment and long term follow up.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• An inability to lie still for the tests
• Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)
• Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded.
• Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication).
• Use of tamoxifen, faslodex, DES or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan.
• Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL)
• Adult patients who require monitored anesthesia for PET scanning.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

16-fluoroestradiol; Magnetic Resonance Spectroscopy; X-Rays; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Hannah Linden, MD
• Organization: UWashington

hmlinden@uw.edu

206-606-2053

Study Officials

• Hannah Linden

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: July 10, 2021
• Primary Completion: October 1, 2021
• Study Completion (Estimated): April 30, 2041
• Last Updated: January 22, 2026
• Results First Posted: February 21, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)