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18F-fluorofuranylnorprogesterone PET/MRI for Endometriosis

Phase 2
Recruiting
Led By Jorge Oldan, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 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
No Placebo-Only Group

Summary

This trial will assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis in 24 participants.

Who is the study for?
This trial is for women aged 18-55 who may have endometriosis, are scheduled for laparoscopy, and haven't taken hormone treatments recently. Participants must be able to consent and not be institutionalized or pregnant. They should not have a history of certain cancers or allergies to contrast used in MRI.
What is being tested?
The study tests the effectiveness of a PET/MRI scan using a tracer called FFNP to diagnose endometriosis in women with symptoms suggestive of the condition. It's a single-group study aiming to determine how well this imaging technique can identify endometriosis.
What are the potential side effects?
Potential side effects could include reactions to the PET tracer FFNP or gadolinium contrast used in MRI, such as allergic reactions, nausea, or dizziness. Kidney function might also be affected if there's pre-existing kidney disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Secondary study objectives
Endometriosis
Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Diagnostic accuracy of PET /MRI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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?

University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,545 Total Patients Enrolled
3 Trials studying Endometriosis
27 Patients Enrolled for Endometriosis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,862 Total Patients Enrolled
15 Trials studying Endometriosis
4,644 Patients Enrolled for Endometriosis
Jorge Oldan, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Endometriosis
8 Patients Enrolled for Endometriosis

Media Library

18F-fluorofuranylnorprogesterone PET / MRI Clinical Trial Eligibility Overview. Trial Name: NCT05480995 — Phase 2
Endometriosis Research Study Groups: 18F-fluorofuranylnorprogesterone PET / MRI
Endometriosis Clinical Trial 2023: 18F-fluorofuranylnorprogesterone PET / MRI Highlights & Side Effects. Trial Name: NCT05480995 — Phase 2
18F-fluorofuranylnorprogesterone PET / MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05480995 — Phase 2
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