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

Primary Purpose

Endometriosis

Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire Réunion
  • CHU de la Réunion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET scanner in addition to MRI

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
number of endometriosis lesions
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
location of endometriosis lesions
Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis
degree of inflammation of the cells

Full Information

First Posted
March 26, 2021
Last Updated
March 1, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT04831619
Brief Title
Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN
Acronym
TEP-ENDORUN
Official Title
Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET scanner in addition to MRI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)
Intervention Description
A PET scan will be performed in the patients included, in addition to the conventional imaging workup (MRI, endovaginal and pelvic ultrasound).
Primary Outcome Measure Information:
Title
To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
Description
Total number of endometriosis lesions diagnosed by the PET scanner
Time Frame
at inclusion (before surgery)
Secondary Outcome Measure Information:
Title
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
Description
number of endometriosis lesions
Time Frame
up to 14 weeks (after surgery)
Title
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
Description
location of endometriosis lesions
Time Frame
up to 14 weeks (after surgery)
Title
Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis
Description
degree of inflammation of the cells
Time Frame
up to 14 weeks (after PET-Scanner)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie AUZANNEAU
Phone
(0)262 35 99 49
Ext
+33
Email
lucie.auzanneau@chu-reunion.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
Phone
(0)262 35 99 49
Ext
+33
Email
lucie.auzanneau@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Peter VON THEOBALD, PHD
Facility Name
CHU de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
Phone
(0)262 35 99 49
Ext
+33
Email
lucie.auzanneau@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Malik BOUKERROU, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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