Using PET imaging to evaluate estrogen receptor activity in uterine cancer

[18F]FLUOROESTRADIOL (FES) PET/CT IMAGING OF THE ESTROGEN RECEPTOR IN PATIENTS WITH METASTATIC OR RECURRENT UTERINE CANCER

This study is testing a special type of imaging to see how well estrogen receptors are working in women with recurrent or advanced uterine cancer to help guide their treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Abramson Cancer Center at Penn Medicine (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05916196 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with recurrent or metastatic uterine cancer that has not been treated with surgery.

Not a fit: Patients who are pregnant or those who have recently discontinued certain hormone therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to tailor treatments for uterine cancer based on estrogen receptor activity, potentially improving patient outcomes.

How similar studies have performed: Other studies utilizing PET imaging for cancer evaluation have shown promise, suggesting that this approach may be beneficial, though this specific application is relatively novel.

Eligibility criteria

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 this trial is running

Philadelphia, Pennsylvania

• 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

Conditions: Uterine Cancer, estrogen receptor PET imaging