18F-fluorofuranylnorprogesterone PET / MRI for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NCEndometrial Cancer+1 More18F-fluorofuranylnorprogesterone PET / MRI - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Upon completion of all study image data collection for all participants [approximately 1 year]

Year 1
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.
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

18F-fluorofuranylnorprogesterone PET / MRI
1 of 1

Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: 18F-fluorofuranylnorprogesterone PET / MRI · No Placebo Group · Phase 2

18F-fluorofuranylnorprogesterone PET / MRI
Drug
Experimental Group · 1 Intervention: 18F-fluorofuranylnorprogesterone PET / MRI · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: upon completion of all study image data collection for all participants [approximately 1 year]

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
82,427 Total Patients Enrolled
9 Trials studying Endometrial Cancer
348 Patients Enrolled for Endometrial Cancer
Radiological Society of North AmericaOTHER
23 Previous Clinical Trials
5,007 Total Patients Enrolled
Jorge Oldan, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.