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[18F]FES PET/CT Imaging for Uterine Cancer
Phase 2
Recruiting
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial studies an imaging test to measure estrogen receptor activity in women w/ recurrent/metastatic uterine cancer. Participants receive imaging tests & results may be shared w/ treating physician.
Who is the study for?
This trial is for women aged 18 or older with recurrent, metastatic, or untreated uterine cancer confirmed by biopsy or imaging. Participants must have at least one lesion outside the liver and cannot be pregnant. Those on tamoxifen or fulvestrant need a washout period before scanning. The study requires informed consent.Check my eligibility
What is being tested?
[18F]Fluoroestradiol (FES) PET/CT scans are being tested to assess estrogen receptor activity in uterine cancer lesions. This may include initial scans before therapy and follow-up scans at disease progression to observe changes in FES uptake.See study design
What are the potential side effects?
The side effects related to [18F]Fluoroestradiol PET/CT are not detailed here but generally could include discomfort from the injection of the tracer, allergic reactions, and typical risks associated with CT imaging such as exposure to radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
rate of FES positivity in ER+ uterine cancer
Secondary outcome measures
Change in FES at progression
Number of FES positive sites compared to standard of care imaging
PFS
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Recurrent or metastatic uterine cancerExperimental Treatment1 Intervention
Women with known or suspected recurrent or metastatic uterine cancer may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania.
[18F]fluoroestradiol (FES) PET/CT imaging will be used to evaluate estrogen receptor (ER) activity in areas of disease known by standard of care imaging (e.g. CT, MRI, Bone Scan, FDG PET/CT, ultrasound) or clinical exam. For patients starting a new line of therapy, imaging will occur prior to starting new therapy. For patients who completed an initial scan and are starting new therapy, some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures (prior to initiation of next line therapy).
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,614 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one cancer spot outside my liver, confirmed by scans.I stopped taking tamoxifen or fulvestrant 8 or 28 weeks ago, respectively, before a FES PET/CT scan.I am 18 years old or older.My uterine cancer has returned, spread, or was never operated on and is confirmed by tests.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent or metastatic uterine cancer
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.
What is the risk associated with Recurrent or metastatic uterine cancer?
"This Phase 2 trial indicates some evidence of safety for patients with recurrent or metastatic uterine cancer, thus receiving a rating of 2. However, there is not yet any data confirming its efficacy."
Answered by AI
Are there any unfilled patient slots in this experiment?
"Clinicaltrials.gov reveals that enrollment for this research project has been concluded as of June 21st, 2023 following its initial posting on July 1st, 2023. While no longer actively recruiting participants, there are 41 other clinical trials in search of candidates at present."
Answered by AI
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