Using PET imaging to evaluate estrogen receptor activity in uterine cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the use of [18F]fluoroestradiol (FES) PET/CT imaging to assess estrogen receptor activity in women with recurrent or metastatic uterine cancer. Eligible participants will undergo FES PET/CT scans to evaluate disease progression and response to therapy, with imaging conducted before starting new treatment or at suspected disease progression. The study aims to enroll up to 30 women who meet specific eligibility criteria, ensuring a thorough evaluation of the imaging technique's effectiveness in guiding treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Participants will be ≥ 18 years of age
2. Recurrent or metastatic or intact non-operated uterine cancer not treated with surgery that is biopsy-proven or demonstrated on other standard of care imaging (e.g. CT, FDG PET/CT, MRI, bone scan, x-ray, ultrasound)
3. At least one lesion outside the liver detected by standard of care imaging (e.g.CT, FDG PET/CT, MRI, bone scan, x-ray, ultrasound)
4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
5. Subjects that are currently on or have recently discontinued tamoxifen or fulvestrant would require an 8-week or 28-week, respectively, washout period prior to FES PET/CT scan.

Exclusion Criteria

1. Females who report they are pregnant at screening will not be eligible for this study. A urine pregnancy test will be performed in women of child-bearing potential prior to FES injection.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Where it's running

• Abramson Cancer Center at University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Neil Taunk, MD — Abramson CC
• Study coordinator: Erin o Schubert
• Email: erin.schubert@pennmedicine.upenn.edu
• Phone: 2155736569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.