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

C

Centre Hospitalier Universitaire de la Réunion

Status and phase

Not yet enrolling
Phase 3

Conditions

Endometriosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04831619
2013/CHU/12

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

PET scanner in addition to MRI
Experimental group
Treatment:
Drug: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)

Trial contacts and locations

2

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Central trial contact

Lucie AUZANNEAU

Data sourced from clinicaltrials.gov

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