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[18F]FES PET/CT Imaging for Uterine Cancer

Phase 2

Recruiting

Led By Neil Taunk, MD

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

rate of FES positivity in ER+ uterine cancer

Secondary study objectives

Change in FES at progression

Number of FES positive sites compared to standard of care imaging

PFS

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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).

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