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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01HD106485-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Experimental | All enrolled subjects will receive the tracer and then have a PET/MRI scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluorofuranylnorprogesterone PET / MRI | Drug | Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Upon completion of all study image data collection for all participants [approximately 1 year] |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Upon completion of all study image data collection for all participants [approximately 1 year] |
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Inclusion Criteria
Exclusion Criteria
Subjects must be assigned the gender of female at birth.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markeela Lipscomb, CCRC | Contact | 919-843-3670 | markeela_lipscomb@med.unc.edu | |
| Hannah Mignosa-Martin | Contact | 984-215-4963 | hannah_mignosa@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Oldan, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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).
Beginning 9 months after and continuing for 36 months following publication
The investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 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. | 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. | Upon completion of all study image data collection for all participants [approximately 1 year] |
| D000091662 | Genital Diseases |