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FES-PET/CT Imaging for Breast Cancer

Q: Are researchers currently seeking participants for this clinical trial?

<p>Affirmative. Information on clinicaltrials.gov reveals that this trial, initially launched March 31st 2021 and modified April 21st 2022, is presently recruiting participants. 6 individuals must be found from 1 unique centre for the study to proceed.</p>

Q: How many individuals have been invited to participate in this research initiative?

<p>Affirmative. Clinicaltrials.gov reveals that the current recruitment status of this trial is active, having been originally announced on March 31st 2021 and last updated on April 21st 2022. The study aims to enrol 6 individuals at a single location.</p>

Phase < 1

Recruiting

Led By Matthew Covington, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Adults aged 18 years or greater

Biopsy proven estrogen receptor positive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will help determine if a new imaging method can help guide cancer treatment decisions.

Who is the study for?

This trial is for adults over 18 with estrogen receptor positive breast cancer who are part of the FORESEE trial and considered unresponsive to hormonal therapies. They must be able to consent and not have severe allergies, claustrophobia that prevents PET/CT scans, or be pregnant/breastfeeding.Check my eligibility

What is being tested?

[18F]Fluoroestradiol (FES) PET/CT imaging is being tested as a tool to help oncologists decide if ER+ metastatic breast cancer patients no longer respond to hormone treatments, which is crucial for the FORESEE trial's design.See study design

What are the potential side effects?

Potential side effects may include allergic reactions specific to radiopharmaceuticals used in FES-PET/CT imaging. However, these are generally rare and participants with significant allergies can join at the Investigator's discretion.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My breast cancer is estrogen receptor positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents

Secondary outcome measures

Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy

Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment: all patientsExperimental Treatment1 Intervention

One session of [18F]FES PET/CT Imaging

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,624 Total Patients Enrolled

15 Trials studying Breast Cancer

7,124 Patients Enrolled for Breast Cancer

Matthew Covington, MDPrincipal InvestigatorHuntsman Cancer Institute

1 Previous Clinical Trials

79 Total Patients Enrolled

Media Library

[18F]Fluoroestradiol (FES) PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04727632 — Phase < 1

Breast Cancer Research Study Groups: Treatment: all patients

Breast Cancer Clinical Trial 2023: [18F]Fluoroestradiol (FES) PET/CT Highlights & Side Effects. Trial Name: NCT04727632 — Phase < 1

[18F]Fluoroestradiol (FES) PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04727632 — Phase < 1

Frequently Asked Questions

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

Are researchers currently seeking participants for this clinical trial?

"Affirmative. Information on clinicaltrials.gov reveals that this trial, initially launched March 31st 2021 and modified April 21st 2022, is presently recruiting participants. 6 individuals must be found from 1 unique centre for the study to proceed."

Answered by AI

How many individuals have been invited to participate in this research initiative?

"Affirmative. Clinicaltrials.gov reveals that the current recruitment status of this trial is active, having been originally announced on March 31st 2021 and last updated on April 21st 2022. The study aims to enrol 6 individuals at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

2021. "[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04727632.