← Back to Search

FES PET/CT Imaging for Breast Cancer

Q: Are there still vacant slots for participants in this experiment?

<p>The clinicaltrials.gov database shows that this research trial is not taking on new candidates at the moment, despite being updated as recently as July 1st 2022. Nevertheless, there are 1404 other studies actively seeking participants currently.</p>

Phase < 1

Waitlist Available

Led By Randy Yeh, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry)

ECOG performance status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new way to image tumors with estrogen receptors to see if it could be used to monitor changes in the tumor during treatment.

Who is the study for?

This trial is for adults with breast cancer that has estrogen receptors, which are targets for certain treatments. Participants must be in fair to good physical condition and able to provide consent. It's not suitable for those under 18, pregnant or breastfeeding women, individuals who can't have PET/CT scans due to size or claustrophobia, or those with high bilirubin or creatinine levels.Check my eligibility

What is being tested?

The study tests a new imaging agent called Fluorestradiol (FES) used during PET/CT scans to visualize the amount of estrogen receptors in tumors. This could help determine if FES is effective in monitoring changes in receptor levels during breast cancer treatment.See study design

What are the potential side effects?

While the document doesn't specify side effects of FES, typical risks may include reactions at the injection site and discomfort from lying still during scanning. The radiation exposure from PET/CT is also a consideration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is estrogen receptor positive.

Select...

I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FES PET/CT scanning

Side effects data

From 2019 Phase 3 trial • 208 Patients • NCT03739684

Headache

Fatigue

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

18F-DCFPyL Injection

Trial Design

1Treatment groups

Experimental Treatment

Group I: (FES) PET/CT for ImagingExperimental Treatment2 Interventions

FES PET/CT studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 5 mCi (+/- 10%) of FES PET/CT will be injected intravenously. 60 (+/- 10) minutes following tracer injection, the patient will be positioned on a GE Discovery PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first, 60-80mAs, 120-140kVp, with a 5mm slice thickness while the patient was free breathing. PET will be acquired at 3-5 minutes per bed position using the 3D mode, approximately 6-7 bed positions. FES PET/CT imaging will take less than 60 minutes. Scans will be reconstructed with iterative reconstruction. If follow-up FES PT/CT scans are performed on a patient, then the same parameters will be used as the initial FES PET/CT scan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorestradiol (FES)

2013

Completed Early Phase 1

~60

PET/CT Imaging

2015

Completed Phase 3

~290

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,566 Total Patients Enrolled

202 Trials studying Breast Cancer

81,083 Patients Enrolled for Breast Cancer

Randy Yeh, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

PET/CT Imaging Clinical Trial Eligibility Overview. Trial Name: NCT01916122 — Phase < 1

Breast Cancer Research Study Groups: (FES) PET/CT for Imaging

Breast Cancer Clinical Trial 2023: PET/CT Imaging Highlights & Side Effects. Trial Name: NCT01916122 — Phase < 1

PET/CT Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT01916122 — Phase < 1

Frequently Asked Questions

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

Are there still vacant slots for participants in this experiment?

"The clinicaltrials.gov database shows that this research trial is not taking on new candidates at the moment, despite being updated as recently as July 1st 2022. Nevertheless, there are 1404 other studies actively seeking participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status

2013. "Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01916122.