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Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-fluorofuranylnorprogesterone PET / MRI
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel HillRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-fluorofuranylnorprogesterone PET / MRI

Arm Description

All enrolled subjects will receive the tracer and then have a PET/MRI scan.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
July 27, 2022
Last Updated
January 27, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05480995
Brief Title
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI
Official Title
Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET / MRI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-fluorofuranylnorprogesterone PET / MRI
Arm Type
Experimental
Arm Description
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
Intervention Type
Drug
Intervention Name(s)
18F-fluorofuranylnorprogesterone PET / MRI
Intervention Description
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer
Primary Outcome Measure Information:
Title
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Description
The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.
Time Frame
Upon completion of all study image data collection for all participants [approximately 1 year]
Title
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Description
The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.
Time Frame
Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of PET /MRI
Description
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).
Time Frame
Upon completion of all study image data collection for all participants [approximately 1 year]
Title
Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
Description
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.
Time Frame
Upon completion of all study image data collection for all participants [approximately 1 year]
Title
Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Description
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.
Time Frame
Upon completion of all study image data collection for all participants [approximately 1 year]

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Subjects must be assigned the gender of female at birth.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markeela Lipscomb, CCRC
Phone
919-843-3670
Email
markeela_lipscomb@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Mignosa-Martin
Phone
984-215-4963
Email
hannah_mignosa@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Oldan, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markeela Lipscomb, CCRC
Phone
919-843-3670
Email
markeela_lipscomb@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Hannah Mignosa-Martin
Phone
984-215-4963
Email
hannah_mignosa@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Jorge Oldan, MD
First Name & Middle Initial & Last Name & Degree
Yueh Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Steven Young, MD
First Name & Middle Initial & Last Name & Degree
Erin Carey, MD
First Name & Middle Initial & Last Name & Degree
Kristen Olinger, MD
First Name & Middle Initial & Last Name & Degree
Lauren Burke, MD
First Name & Middle Initial & Last Name & Degree
Lauren Schiff, MD
First Name & Middle Initial & Last Name & Degree
Robert Huynh, PharmD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
Beginning 9 months after and continuing for 36 months following publication
IPD Sharing Access Criteria
The investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Learn more about this trial

Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

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