F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy

NCT02149173 | Terminated Results FDA Drug

• 5 other identifiers: 7184NCI-2013-02342P01CA042045U01CA148131RG1711032
• Study Type: interventional
• Target: 29
• 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; 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), Assessed by a One-sample Test of the Percent Change in FES SUV

  Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero.

  from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

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

  Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible.

  from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

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

  The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval.

  from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 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.

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

Interventions

Computed Tomography PROCEDURE

Undergo F-18 FES PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Diagnostic (F-18 FES PET/CT)

F-18 16 Alpha-Fluoroestradiol DRUG

Undergo F-18 FES PET/CT

Also known as: 16 alpha-fluroestradiol-17 beta, F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol, Fluoroestradiol F-18

Diagnostic (F-18 FES PET/CT)

Fludeoxyglucose F-18 DRUG

Undergo FDG PET/CT

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Diagnostic (F-18 FES PET/CT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (F-18 FES PET/CT)

Positron Emission Tomography PROCEDURE

Undergo F-18 FES PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

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, diethylstilbestrol (DES) or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan
• Unwillingness or inability to give informed consent
• Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL)
• Adult patients who require monitored anesthesia for PET scanning

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

16-fluoroestradiol; Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Hannah M Linden
• Organization: University of Washington

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 29, 2014
• Study Start: September 15, 2010
• Primary Completion: December 27, 2018
• Study Completion: January 13, 2021
• Last Updated: June 30, 2021
• Results First Posted: February 11, 2020

Record last verified: 2021-06

Locations

US (1)