NCT05916196 [18F]FES PET/.CT in Uterine Cancer
| NCT ID | NCT05916196 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Uterine Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-05 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-04-05 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Neil Taunk, MD
PRINCIPAL INVESTIGATOR
Abramson CC
Frequently Asked Questions
Who can join the NCT05916196 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Uterine Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05916196 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05916196 currently recruiting?
Yes, NCT05916196 is actively recruiting participants. Contact the research team at erin.schubert@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05916196 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05916196 clinical trial?
NCT05916196 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Neil Taunk, MD at Abramson CC. The trial plans to enroll 30 participants.
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