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FES PET/CT Imaging for Metastatic Breast Cancer
Phase 2
Waitlist Available
Led By David Mankoff, MD. PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will use PET/CT imaging to study how well the investigational drug [18F]fluoroestradiol works in treating patients with metastatic breast cancer.
Who is the study for?
This trial is for adults with breast cancer that has spread and worsened despite hormone therapy. They must have at least one tumor outside the liver visible on scans, understand the study's experimental nature, and consent to participate. Pregnant women or those with HER2/neu positive cancer are excluded.Check my eligibility
What is being tested?
[18F]FES PET/CT imaging is being tested to assess estrogen receptor activity in metastatic breast cancer using a new tracer called [18F]fluoroestradiol (FES). The goal is to see how well FES shows ER activity in tumors.See study design
What are the potential side effects?
As this trial involves an imaging procedure rather than a drug treatment, side effects may include discomfort from lying still during the scan and exposure to radiation typical of PET/CT scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My breast cancer got worse while on hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate [18F]FES PET/CT Uptake
Secondary outcome measures
Compare FES Uptake Measures at Baseline and Progression
Correlate FES uptake measures with number of ER+ Circulating Tumor Cells
Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FES PET/CTExperimental Treatment1 Intervention
All subjects will receive an [18F]FES PET/CT scan.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,082 Total Patients Enrolled
28 Trials studying Breast Cancer
26,360 Patients Enrolled for Breast Cancer
David Mankoff, MD. PhDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: FES PET/CT
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has [18F]FES been authorized by the FDA?
"Our experts at Power estimate [18F] FES to possess an intermediate safety rating of 2, as Phase 2 trials have only provided limited evidence for its security and no data on efficacy."
Answered by AI
Are any new participants being recruited for this investigation?
"As per the information present on clinicaltrials.gov, this study is no longer enrolling patients; its initial posting was dated May 1st 2015 and it was recently modified July 5th 2022. Nevertheless, there are an abundance of other trials looking for participants right now - 2297 to be precise."
Answered by AI
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