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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
Study 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
1,506 Previous Clinical Trials
4,190,537 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
1,964 Previous Clinical Trials
2,674,706 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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study have an age limit and, if so, what is it?
"The minimum age for participation in this trial is 18, with the cut-off for eligibility being 55 years old."
Answered by AI
Has the FDA cleared 18F-fluorofuranylnorprogesterone PET / MRI for use?
"This is a Phase 2 trial, which means that while there are some data supporting safety, none support efficacy. Given this information, our team at Power has rated the 18F-fluorofuranylnorprogesterone PET / MRI as a 2 in terms of safety."
Answered by AI
How many people are currently participating in this experiment?
"That is correct. The page on clinicaltrials.gov dedicated to this particular trial says that it is currently looking for 24 more participants, having originally posted the study on November 1st, 2022."
Answered by AI
Who does this research include in its sample size?
"Eligible participants for this study must have endometrioma and be between 18-55 years old. There are currently around 24 people enrolled in the trial."
Answered by AI
Are we still enrolling new participants for this research project?
"That is correct, the online information from clinicaltrials.gov reveals that this study is still recruiting patients. The trial was posted on November 1st, 2022 and updated recently on November 2nd, 2022. They are looking for a total of 24 participants from 1 site."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
After 2+ years of unexplained infertility, I was finally evaluated for endometriosis. In retrospect, my providers should have screened this for me sooner as I had some of the common symptoms, though, admittedly I thought they were just part of menstruation. I want to do everything I can to create awareness for the condition and helping improve screening for and treatment of endometriosis.
PatientReceived no prior treatments
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