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NCT Number: NCT05480995

Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone 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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Erin Carey, MD

SUB_INVESTIGATOR

Hannah Mignosa-Martin

CONTACT

[email protected]

984-215-4963

Jorge Oldan, MD

PRINCIPAL_INVESTIGATOR

Kristen Olinger, MD

SUB_INVESTIGATOR

Lauren Burke, MD

SUB_INVESTIGATOR

Lauren Schiff, MD

SUB_INVESTIGATOR

Markeela Lipscomb, CCRC

CONTACT

[email protected]

919-843-3670

Robert Huynh, PharmD

SUB_INVESTIGATOR

Steven Young, MD

SUB_INVESTIGATOR

Yueh Lee, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

18F-fluorofuranylnorprogesterone PET / MRI

Drug

Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Diagnostic accuracy of PET /MRI

    Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]

    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).

  2. 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]

    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.

  3. 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]

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Mignosa-Martin

CONTACT

[email protected]

984-215-4963

Markeela Lipscomb, CCRC

CONTACT

[email protected]

919-843-3670

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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