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FES PET/CT Imaging for Predicting Treatment Response in Breast Cancer

Phase 2
Waitlist Available
Led By Farrokh Dehdashti
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) or non-measurable but must be present in at least one non-liver site, where presence is defined as 1.5 cm or greater and visualized on PET/CT with [18F]-fluorodeoxyglucose (FDG); patients with effusion only disease or disease only in the liver are not eligible for the study
Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial will study using F-18 16 alpha-fluoroestradiol positron emission tomography/computed tomography to see if it can help predict response to endocrine therapy in patients with newly diagnosed breast cancer.

Who is the study for?
This trial is for postmenopausal women, men, or premenopausal women planning to receive standard endocrine therapy for newly diagnosed metastatic breast cancer that's estrogen-receptor positive. Participants must have a life expectancy over 6 months, be able to lie still for PET/CT scans, and not have received prior endocrine therapy for metastatic disease. They should not be in liver failure or have had more than one line of chemotherapy for metastatic disease.Check my eligibility
What is being tested?
The study tests if F-18 16 alpha-fluoroestradiol (FES) PET/CT can predict the response of metastatic breast cancer to endocrine therapy. FES is a radioactive hormone that highlights cancer in the body during imaging procedures, potentially helping doctors anticipate treatment effectiveness.See study design
What are the potential side effects?
As this trial focuses on diagnostic procedures rather than drug treatments, side effects are minimal but may include discomfort from lying still during scans and exposure to radiation typical of PET/CT imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be seen on scans and is not only in my liver.
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I have no allergies to compounds similar to 18F-FES.
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My breast cancer has spread and was confirmed by a tissue test.
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I can stay still for up to 30 minutes.
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I am not planning to receive targeted or HER2 therapy along with hormone therapy.
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My cancer is not HER2 positive.
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I am using or willing to use effective birth control during the study.
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I have not had hormone therapy for my advanced cancer.
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I am postmenopausal, a man, or premenopausal and planned for standard hormone therapy after a specific scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease
Secondary outcome measures
FES SUVmax
FES SUVmax < 1.5 as the optimal cutpoint for predicting PFS
FES uptake, as measured by SUVmax and semi-quantitative ER from IHC
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (FES PET/CT)Experimental Treatment4 Interventions
Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,054 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Farrokh DehdashtiPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Laboratory Biomarker Analysis Clinical Trial Eligibility Overview. Trial Name: NCT02398773 — Phase 2
Breast Cancer Research Study Groups: Diagnostic (FES PET/CT)
Breast Cancer Clinical Trial 2023: Laboratory Biomarker Analysis Highlights & Side Effects. Trial Name: NCT02398773 — Phase 2
Laboratory Biomarker Analysis 2023 Treatment Timeline for Medical Study. Trial Name: NCT02398773 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is F-18 16 Alpha-Fluoroestradiol safe for human consumption?

"Despite limited proof of efficacy, the safety profile for F-18 16 Alpha-Fluoroestradiol has been evaluated and assigned a score of 2."

Answered by AI

Is it possible to enrol in this experiment presently?

"Unfortunately, this clinical trial is no longer recruiting volunteers. It first appeared on February 2nd 2016 and was last updated on November 8th 2022. Looking for other studies? Currently, there are 2282 active recruitment trials targeting HER2/NEU negative patients, as well as 10 different F-18 16 Alpha-Fluoroestradiol related medical research projects in need of participants."

Answered by AI

Are there numerous healthcare centers conducting this study within the city bounds?

"This trial is enlisting patients from 13 sites, some of which are located in Los Angeles, Philadelphia and Waukesha. To reduce travel-related burdens, it's best to select the site nearest you when enrolling for this study."

Answered by AI

Are there any analogous trials using the radioisotope F-18 16 Alpha-Fluoroestradiol?

"F-18 16 Alpha-Fluoroestradiol was initially studied in 2016 at the Indiana University/Melvin and Bren Simon Cancer Center, with a total of 615 concluded medical trials. Currently 10 active studies are utilizing this medication, primarily located within Los Angeles, California."

Answered by AI

How many participants are being monitored in this research?

"At the moment, this trial is not actively enrolling new patients. Initially posted on February 2nd 2016 and last updated November 8th 2022, another avenue of exploration may be to search for one of the 2288 studies currently admitting participants with her2/neu negative or any of the 10 trials that are permitting F-18 16 Alpha-Fluoroestradiol applicants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
2016. "FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02398773.
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~10 spots leftby Apr 2025
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