Evaluatie van endometriose met 18F-fluorofuranylnorprogesteron PET / MRI
Evaluatie van endometriose met 18F-fluorfuranylnorprogesteron Positronemissietomografie-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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- University of North Carolina at Chapel Hill
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 18F-fluorofuranylnorprogesterone PET / MRI
All enrolled subjects will receive the tracer and then have a PET/MRI scan. |
Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Tijdsspanne: Upon completion of all study image data collection for all participants [approximately 1 year]
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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]
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Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Tijdsspanne: Upon completion of all study image data collection for all participants [approximately 1 year]
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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]
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Diagnostic accuracy of PET /MRI
Tijdsspanne: Upon completion of all study image data collection for all participants [approximately 1 year]
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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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Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates
Tijdsspanne: Upon completion of all study image data collection for all participants [approximately 1 year]
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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]
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Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates
Tijdsspanne: Upon completion of all study image data collection for all participants [approximately 1 year]
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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]
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jorge Oldan, MD, University of North Carolina, Chapel Hill
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 22-1175
- 1P01HD106485-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
Beginning 9 months after and continuing for 36 months following publication
IPD-toegangscriteria voor delen
The investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
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