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FES-PET/CT Imaging for Breast Cancer
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
Biopsy proven estrogen receptor positive breast cancer
Be older than 18 years old
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 βYesβ for the criteria belowSelect...
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
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
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Who is running the clinical trial?
University of UtahLead Sponsor
1,103 Previous Clinical Trials
1,781,711 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently hospitalized or in need of urgent care.I am 18 years old or older.You are too scared of small, enclosed spaces to have a PET/CT scan.My breast cancer is estrogen receptor positive.Doctors in the FORESEE trial have determined that hormonal treatments have not been effective for you.You need to be put to sleep for the PET/CT scan.You have had a bad reaction to a radiopharmaceutical before, or you have serious allergies or autoimmune diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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