RecruitingPhase 2NCT05916196

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

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

30 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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). The selection of therapy will be made by a treating physician and will not be affected by participation in this imaging study. Results of the FES PET/CT scan may be shared with the treating physician or subject by request but will not be used to make clinical decisions about treatment.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Participants will be ≥ 18 years of age
  • 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)
  • 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)
  • 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.
  • 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 Criteria3

  • 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.
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • 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

Interventions

DRUG18F-Fluoroestradiol

18F-FES PET/CT


Locations(1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05916196


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