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FES PET/CT Imaging for Breast Cancer

Phase 2
Waitlist Available
Led By Gary Ulaner, MD, PhD
Research Sponsored by Hoag Memorial Hospital Presbyterian
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0 to 2
For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or for cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial suggests that a new imaging technique, FES PET/CT, may be better at detecting breast cancer metastases than the current standard of care.

Who is the study for?
This trial is for women over 18 with ER-positive breast cancer, either locally advanced (Stage 2B-3C) or suspected recurrence. They must be able to follow the study plan and have stopped certain hormone therapies for specific periods. Pregnant or breastfeeding women, those over 450 pounds who can't use a PET/CT scanner, or anyone with conditions affecting safety/data quality cannot join.Check my eligibility
What is being tested?
The trial is testing a new type of PET scan using an imaging agent called FES that targets estrogen receptors common in breast cancers. It aims to see if this method is better at spotting where the cancer has spread compared to standard CT scans and bone scans recommended by NCCN guidelines.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions related to the injection of FES tracer such as pain at injection site, allergic reactions, and exposure to radiation from the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to perform daily activities without help or with a little help.
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For cohort 1: You have locally advanced cancer and need a scan to see if it has spread. For cohort 2: You might have cancer come back and need a scan to check.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of unsuspected distant metastases
Secondary outcome measures
Detection of suspected disease recurrence

Trial Design

2Treatment groups
Experimental Treatment
Group I: Suspected disease recurrenceExperimental Treatment1 Intervention
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive breast cancer and suspected disease recurrence
Group II: Initial StagingExperimental Treatment1 Intervention
FES PET/CT will be compared to CT/bone scan for detection of unsuspected distant metastases in patients with ER-positive locally advanced breast cancer

Find a Location

Who is running the clinical trial?

Hoag Memorial Hospital PresbyterianLead Sponsor
34 Previous Clinical Trials
14,571 Total Patients Enrolled
2 Trials studying Breast Cancer
224 Patients Enrolled for Breast Cancer
Gary Ulaner, MD, PhDPrincipal Investigator - Hoag Family Cancer Institute
Hoag Memorial Hospital Presbyterian
4 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

18F-fluoroestradiol PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04883814 — Phase 2
Breast Cancer Research Study Groups: Suspected disease recurrence, Initial Staging
Breast Cancer Clinical Trial 2023: 18F-fluoroestradiol PET/CT Highlights & Side Effects. Trial Name: NCT04883814 — Phase 2
18F-fluoroestradiol PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883814 — Phase 2

Frequently Asked Questions

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

What is the sample size of this research endeavor?

"Indeed, the clinical trial is open for enrolment. The study was initially posted on January 15th 2021 and has undergone a recent update as of January 5th 2022. It aims to recruit 124 people across one medical centre."

Answered by AI

Is there an open call for participants in this clinical experiment?

"That is correct. According to the details published on clinicaltrials.gov, this medical research project - which was originally announced on 15th January 2021 - is actively recruiting participants. 124 people are required for 1 site at present time."

Answered by AI

Does the FDA officially sanction 18F-fluoroestradiol PET/CT scanning?

"Our team at Power has determined that 18F-fluoroestradiol PET/CT is relatively safe, earning it a score of 2. This rating denotes the presence of safety data but no efficacy evidence due to this being an early phase two trial."

Answered by AI
~30 spots leftby Mar 2025