Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Endometriosis
The main objective is to study the use of a new diagnostic tool: [18F]-FES PET/CT in the detection and characterisation of endometriosis lesions in association with pain.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 23 Mar 2026 → ongoing
- Decision date (initial)
- 2025-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The main objective is to study the use of a new diagnostic tool: [18F]-FES PET/CT in the detection and characterisation of endometriosis lesions in association with pain.
Secondary objectives 4
- Characterize endometriosis lesions according to their anatomical location.
- Characterize endometriosis lesions according to pain symptomatology.
- Compare the relevance of MRI versus PET in the diagnosis of deep and superficial endometriosis lesions.
- Identify a correlation between estrogen receptor expression, PET analysis and pain intensity.
Conditions and MedDRA coding
Endometriosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10014778 | Endometriosis | 100000004872 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Test: Painful patients with VAS ≥ 4 treated surgically for painful symptoms related to endometriosis
- Control: Patient with VAS < 4 treated surgically for endometriosis in the context of infertility
- Age > 18 years old
- Patient with informed consent
- Patients with preoperative MRI not contraindicated for [18F]-FES PET/CT
- Patient operated on mid-cycle
- Membership of a Social Security scheme
Exclusion criteria 7
- Patient treated for endometriosis without surgery
- Pregnant patient
- Claustrophobic patient
- Hypersensitivity to the active substance (Fluoroestradiol(18F)) or to one of the excipients
- Patient under legal protection
- Patient taking hormonal treatment
- Menopausal patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Characterization of the hypermetabolism of lesions on PET by analysis of SUV: Hypermetabolism present or not and quantification
Secondary endpoints 4
- Analyzes of lesions in Immunohistochemistry (IHC) and results of in situ hybridization: Characterization of the markings (intensity, type of receptor expressed, etc.) for each lesion depending on the anatomical location.
- Analyzes of lesions in Immunohistochemistry and results of in situ hybridization: Characterization of the markings (intensity, type of receptor expressed, etc.) for each patient according to pain (VAS)
- Sensitivity of [18F]-FES PET/CT compared to that of MRI in the diagnosis of superficial and deep endometriosis lesions and according to their location
- Degree of association between [18F] SUV intensity and ER expression (IHC) and pain intensity (VAS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
EstroTep 500 MBq/mL, solution injectable
PRD11510725 · Product
- Active substance
- Fluoroestradiol F-18
- Substance synonyms
- FLUOROESTRADIOL (18F), 16ALFA-[18F]FLUORO-17BETA-ESTRADIOL
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 280 MBq megabecquerel(s)
- Max total dose
- 280 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX11 — -
- Marketing authorisation
- 34009 550 243 0 9
- MA holder
- GE HEALTHCARE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Toulouse
- Sponsor organisation
- Centre Hospitalier Universitaire De Toulouse
- Address
- 2 Rue Viguerie
- City
- Toulouse
- Postcode
- 31300
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- Ariane WEYL
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Toulouse
- Contact name
- Caroline Peyrot
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Chirurgie gynécologique, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-03-23 | 2026-03-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-520637-24-00 | 2.1 |
| Protocol (for publication) | D1_Protocol 2025-520637-24-00_TC | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | M2_Liste centres et investigateurs | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adultes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adultes_TC | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Estrotep | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Resume des donnees cliniques et non cliniques 2025-520637-24-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-520637-24-00 | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-520637-24-00_TC | 2.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-06 | France | Acceptable 2025-05-15
|
2025-05-23 |