Estrogen Receptor PositiveNCT02149173

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

A study testing Computed Tomography, F-18 16 Alpha-Fluoroestradiol and Fludeoxyglucose F-18 in people with Estrogen Receptor Positive and Recurrent Breast Carcinoma, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Estrogen Receptor Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
What is being tested?: Computed Tomography, F-18 16 Alpha-Fluoroestradiol and Fludeoxyglucose F-18
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2010to 13 Jan 2021
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-Targeted Therapy

Read the detailed description

PRIMARY OBJECTIVES:

Measure the effect of endocrine targeted therapy on estrogen receptor (ER) expression and estradiol binding to the receptor using serial FES PET and fludeoxyglucose F-18 (FDG) PET.

SECONDARY OBJECTIVES:

Document the safety profile of FES PET in patients with breast cancer.

II. Examine associations between FES PET results and serial measurements of hormone or other levels in peripheral blood, as related to efficacy of endocrine-targeted therapy. Correlate FES PET uptake measures with histopathological assays and tumor microenvironment studies on biopsy specimens, if relevant to specific treatment regimen.

OUTLINE:

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.

After completion of study, patients are followed up for up to 20 years.

Conditions: Estrogen Receptor Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Being tested: Computed Tomography, F-18 16 Alpha-Fluoroestradiol, Fludeoxyglucose F-18, Laboratory Biomarker Analysis, Positron Emission Tomography
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo F-18 FES PET/CT
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo FDG PET/CT
F-18 16 Alpha-FluoroestradiolDrug
Also called 16 alpha-fluroestradiol-17 beta, F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol
Undergo F-18 FES PET/CT
Fludeoxyglucose F-18Drug
Also called 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18
Undergo FDG PET/CT
Laboratory Biomarker AnalysisOther
Correlative studies
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo F-18 FES PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo FDG PET/CT

Study groups in NCT02149173
Study group	Role	What they receive
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. Receives: Procedure: Computed Tomography; Drug: F-18 16 Alpha-Fluoroestradiol; Drug: Fludeoxyglucose F-18; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression,
Measured: from start of therapy up to 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201013 Jan 2021

First posted29 May 2014 (estimated)
Study start15 Sep 2010
Primary completion27 Dec 2018
Study completion13 Jan 2021

Why it stopped: Terminated due to low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Estrogen Receptor PositiveStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02149173
Sponsor's protocol ID: 7184
Other IDs: NCI-2013-02342, 7184, P01CA042045, U01CA148131, RG1711032
Status last verified: Jun 2021
First submitted: 1 May 2014
Last updated: 30 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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