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Utvärdering av endometrios med 18F-fluorfuranylnorprogesteron PET/MRT

2 november 2026 uppdaterad av: University of North Carolina, Chapel Hill

Utvärdering av endometrios med 18F-fluorfuranylnorprogesteron 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

9

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • University of North Carolina at Chapel Hill

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Tidsram: 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.

Upon completion of all study image data collection for all participants [approximately 1 year]
Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis
Tidsram: 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.

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic accuracy of PET /MRI
Tidsram: 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).

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
Tidsram: 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.

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
Tidsram: 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.

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Jorge Oldan, MD, University of North Carolina, Chapel Hill

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 januari 2023

Primärt slutförande (Faktisk)

27 juli 2026

Avslutad studie (Faktisk)

27 juli 2026

Studieregistreringsdatum

Först inskickad

27 juli 2022

Först inskickad som uppfyllde QC-kriterierna

27 juli 2022

Första postat (Faktisk)

29 juli 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 januari 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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).

Tidsram för IPD-delning

Beginning 9 months after and continuing for 36 months following publication

Kriterier för IPD Sharing Access

The investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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