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Corticosteroid

18F-fluorofuranylnorprogesterone PET / MRI for Endometrial Cancer

Phase 2
Waitlist Available
Led By Jorge Oldan, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned treatment with levonorgestrel-releasing intrauterine device (LR-IUD) for CAH or grade 1 EC
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon completion of all study image data collection for all participants [approximately 1 year]
Awards & highlights

Study Summary

This trial is testing if a PET/MRI scan can predict how well Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy works for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).

Eligible Conditions
  • Endometrial Cancer
  • Complex Atypical Hyperplasia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have planned treatment with a certain type of intrauterine device (IUD) for a medical condition called CAH or a mild form of uterine cancer called grade 1 EC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of all study image data collection for all participants [approximately 1 year]
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of all study image data collection for all participants [approximately 1 year] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients
Secondary outcome measures
Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.
Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-fluorofuranylnorprogesterone PET / MRIExperimental Treatment1 Intervention
All enrolled subjects will receive the tracer and then have a PET/MRI scan.

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,236 Total Patients Enrolled
9 Trials studying Endometrial Cancer
322 Patients Enrolled for Endometrial Cancer
Radiological Society of North AmericaOTHER
25 Previous Clinical Trials
1,811 Total Patients Enrolled
Jorge Oldan, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with 18F-fluorofuranylnorprogesterone PET / MRI scans?

"We have rated the safety of 18F-fluorofuranylnorprogesterone PET / MRI as a 2. This is due to it being in Phase 2 trials, where there is evidence for safety but not efficacy."

Answered by AI

Are patients presently being recruited for this trial?

"The study, which is currently seeking participants, was originally posted on September 8th 2022 and was last updated on October 18th of the same year."

Answered by AI
~2 spots leftby Sep 2024