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Completed

NCT Number: NCT04831619

Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions.

The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire Réunion, Saint-Denis, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient aged over 18 and under 50
  • Patient with symptomatic endometriosis with indication for surgery
  • Showing at least one typical endometriosis lesion on MRI, greater than 5mm
  • Accepting surgical management
  • Having signed an informed consent after information
  • Affiliate or beneficiary of a social security scheme

Exclusion criteria

  • Patient who has received an injection with GnRH (gonadotropin-releasing hormone ) analogues for less than 3 months (because it induces the quiescence of the disease which is no longer stimulated by estrogen secretion)
  • Patient with a history of heavy abdominopelvic surgery
  • Diabetic patient
  • Patient unable to understand the interest of the study
  • Patient already included in another therapeutic trial with an experimental molecule.
  • Persons referred to in articles L1121-5 to L1121-8 of the PHC (public health code) (corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person making the subject to a legal protection measure: guardianship or curators)
  • Contraindications to PET Scanner (major claustrophobia, contraindication or hypersensitivity to 18-FDG or one of its excipients, contraindication or hypersensitivity to Ultravist® or one of its excipients, etc.)
  • Contraindication to surgery or anesthesia

Treatment and study plan

PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)

Drug

A PET scan will be performed in the patients included, in addition to the conventional imaging workup (MRI, endovaginal and pelvic ultrasound).

Primary outcomes

  1. To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.

    Time frame: at inclusion (before surgery)

    Total number of endometriosis lesions diagnosed by the PET scanner

Secondary outcomes

  1. Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions

    Time frame: up to 14 weeks (after surgery)

    number of endometriosis lesions

  2. Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions

    Time frame: up to 14 weeks (after surgery)

    location of endometriosis lesions

  3. Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis

    Time frame: up to 14 weeks (after PET-Scanner)

    degree of inflammation of the cells

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

Acronym: TEP-ENDORUN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2021
Registry last updated
May 4, 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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