Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
ID05916196

[18F]FLUOROESTRADIOL (FES) PET/CT Imaging of the Estrogen Receptor in Patients with Metastatic or Recurrent Uterine Cancer

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-06-05

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a new imaging method called [18F]fluoroestradiol (FES) PET/CT to study estrogen receptor activity in women with recurrent, metastatic, or non-operated uterine cancer. This phase II study aims to understand how estrogen receptors are present in the cancer, which could help guide future research and treatments. The study involves women who are at least 18 years old and receiving care at the University of Pennsylvania. Participants will undergo up to two PET/CT scans using the investigational FES tracer. The first scan is required and happens before starting a new therapy. Some patients may have a second optional scan if their disease progresses, to compare changes in estrogen receptor activity. The choice of therapy will remain with the treating doctor and will not be influenced by the scan results. Optional biopsies and blood samples may also be collected to study tumor cells and hormone levels. During the study, participants will have scans from the skull base to mid-thigh about 60 minutes after receiving the FES injection. Researchers will review standard imaging and clinical exams to evaluate cancer sites. Optional blood draws will analyze circulating tumor cells and hormone levels. The main outcome measured is the rate of FES positivity in estrogen receptor-positive uterine cancer over one year. Safety, progression, and changes in imaging and pathology will also be monitored. Participation may last up to several years as outcomes and progression are followed.

CONDITIONS

Brief Title

[18F]FES PET/.CT in Uterine Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants will be 18 years of age or older
  • Diagnosis of recurrent, metastatic, or intact non-operated uterine cancer confirmed by biopsy or standard imaging
  • At least one lesion outside the liver detected by standard imaging
  • Ability and willingness to provide written informed consent
  • Patients currently on or recently stopped tamoxifen or fulvestrant must complete an 8-week or 28-week washout period respectively before the scan
Not Eligible

You will not qualify if you...

  • Females who are pregnant at screening
  • Inability to tolerate imaging procedures as judged by the investigator or treating physician
  • Any current medical condition or illness that may compromise participant safety or successful study participation as assessed by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo up to two FES PET/CT scans to evaluate estrogen receptor activity in metastatic or recurrent uterine cancer. The first scan is required and the second is optional at the time of disease progression.

1 or 2 visits (in-person) depending on disease progression

Trial Site Locations

Total: 1 location

1

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

E

Erin o Schubert

S

Shannon Long

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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