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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
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon completion of all study image data collection for all participants [approximately 1 year]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon completion of all study image data collection for all participants [approximately 1 year]
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/MR for evaluating endometriosis
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Secondary outcome measures
Endometriosis
Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Diagnostic accuracy of PET /MRI
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.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,197,213 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
1,988 Previous Clinical Trials
2,683,499 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am male.I haven't taken hormone therapies like progestin or GnRH analogues in the last 10-16 days.I am 18 years old or older.My doctor suspects I have endometriosis based on my symptoms.I have a history of breast, ovarian, or endometrial cancer.I am scheduled for a laparoscopy and haven't taken hormone treatment for at least two cycles.I am not allergic to gadolinium contrast and my kidney function is normal.I am a woman aged between 18 and 55.My doctor suspects I have endometriosis based on my symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-fluorofuranylnorprogesterone PET / MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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