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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04831619
Acronym
TEP-ENDORUN
Enrollment
15
Registered
2021-04-05
Start date
2023-12-12
Completion date
2025-04-24
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

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.

Interventions

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

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

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.at inclusion (before surgery)Total number of endometriosis lesions diagnosed by the PET scanner

Secondary

MeasureTime frameDescription
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesionsup to 14 weeks (after surgery)number of endometriosis lesions
Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosisup to 14 weeks (after PET-Scanner)degree of inflammation of the cells

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026