Contribution of PET (positron emission tomography) scans for the preoperative assessment of symptomatic endometriosis lesions: TEP-ENDORUN

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De La Reunion

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

12 Dec 2023 → 24 Apr 2025

Decision date (initial)

2025-01-29

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520423-88-00

EudraCT number

2019-004361-40

ClinicalTrials.gov

NCT04831619

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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

Secondary objectives 2

1. Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
2. Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis

Conditions and MedDRA coding

Endometriosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient aged over 18 and under 50
2. Patient with symptomatic endometriosis with indication for surgery
3. Patient showing at least one typical endometriosis lesion on MRI, greater than 5mm
4. Patient accepting surgical management
5. Patient having signed an informed consent after information
6. Patient affiliate or beneficiary of a social security scheme

Exclusion criteria 11

1. 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)
2. Patient with a history of heavy abdominopelvic surgery
3. Diabetic patient
4. Patient with contraindication to surgery or anesthesia
5. Patient unable to understand the interest of the study
6. Patient with 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.)
7. Patient already included in another therapeutic trial with an experimental molecule
8. 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)
9. Positive plasma HCG assay in the days preceding the PET scan;
10. Use of corticosteroids and anti-inflammatory drugs within 7 days prior to PET scan For patients with a chronic pathology requiring long-term treatment with corticosteroids and/or use of corticosteroids and anti-inflammatory drugs within 7 days prior to PET scan
11. Blood glucose > 1.6 g/L e on day of PET Scanner

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
2. Number of locations identified by PET scan compared with number of locations identified during surgery.

Secondary endpoints 2

1. SUV threshold to identify endometriosis lesions.
2. Number of lesions visible on PET scan and not visible on MRI, location on PET scan compared with MRI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De La Reunion

Sponsor organisation

Centre Hospitalier Universitaire De La Reunion

Address

Allee Des Topazes, Cs 11021 Cs 11021

City

St Denis

Postcode

97400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De La Reunion

Contact name

TRAN

Public contact point

Organisation

Centre Hospitalier Universitaire De La Reunion

Contact name

TRAN

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications