EndometriosisPhase 2NCT05480995
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
A Phase 2 study testing 18F-fluorofuranylnorprogesterone PET / MRI in people with Endometriosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis. Participants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- 18F-fluorofuranylnorprogesterone PET / MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 27 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 or older
- Female of childbearing age (18-55 years)
- Clinically suspected (symptomatic) endometriosis as defined by referring physician (this would also include endometriomas as other disease may be present).
- Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
- Able to provide informed consent
Who cannot join
- Male
- Institutionalized subject (prisoner or nursing home patient)
- Known history of breast, ovarian or endometrial cancer.
- Pregnant or breast-feeding women
- Chronic progestin-containing medications or Gonadotropin-releasing hormone (GnRH) analogues in the last 10-16 days (or 2 cycles in the case of GnRH analogues as these are dosed monthly) or inability to discontinue these medications
- Allergy to gadolinium contrast or Glomerular Filtration Rate (GFR) below 30 ml/min.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis.
Participants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis.
Procedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of endometriosis.
- Conditions
- Endometriosis
- Being tested
- 18F-fluorofuranylnorprogesterone PET / MRI
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorofuranylnorprogesterone PET / MRIDrug
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Experimental | All enrolled subjects will receive the tracer and then have a PET/MRI scan. Receives: Drug: 18F-fluorofuranylnorprogesterone PET / MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary outcomes (3)
Diagnostic accuracy of PET /MRI
Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and/or by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination).
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and/or by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination). EHP-30 score is this is the arithmetic mean of 30 questions, each rated 0-100, about function and pain with endometriosis, where 0 indicates the best health status through to 100 worst health status. Scale scores for each scale are calculated from the total of the raw scores of each item in the scale divided by the maximum possible raw score of all the items in the scale, multiplied by 100. The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and/or by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination). The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". The investigators will implement a random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start17 Jan 2023
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jorge Oldan, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480995
- Sponsor's protocol ID
- 22-1175
- Other IDs
- 1P01HD106485-01
- Status last verified
- Jan 2026
- First submitted
- 27 Jul 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
- ClinicalTrials.gov ID
- NCT05480995
- Acronym / sponsor ID
- 22-1175
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis.
Participants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis.
Procedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of endometriosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Experimental | Drug: 18F-fluorofuranylnorprogesterone PET / MRIAll enrolled subjects will receive the tracer and then have a PET/MRI scan. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Female of childbearing age (18-55 years)
- Clinically suspected (symptomatic) endometriosis as defined by referring physician (this would also include endometriomas as other disease may be present).
- Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Male
- Institutionalized subject (prisoner or nursing home patient)
- Known history of breast, ovarian or endometrial cancer.
- Pregnant or breast-feeding women
- Chronic progestin-containing medications or Gonadotropin-releasing hormone (GnRH) analogues in the last 10-16 days (or 2 cycles in the case of GnRH analogues as these are dosed monthly) or inability to discontinue these medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRISubjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer | Drug | 18F-fluorofuranylnorprogesterone PET / MRI |
Primary outcome
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.
3 secondary outcomes
Diagnostic accuracy of PET /MRI
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Oldan, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-fluorofuranylnorprogesterone PET / MRI in people with Endometriosis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis (time frame: Upon completion of all study image data collection for all participants [approximately 1 year]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.