Clinical trial • Phase IV • Other
FLUOROESTRADIOL F-18 for Endometriosis
Phase IV trial of FLUOROESTRADIOL F-18 for Endometriosis.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Endometriosis
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 06-03-2025
- First CTIS Authorization Date
- 23-05-2025
Trial design
Control group: patients with VAS < 4 treated surgically for endometriosis (infertility context); Test group: painful patients with VAS ≥ 4 treated surgically. Imaging comparator: MRI versus [18F]-FES PET/CT for lesion detection and characterization. Phase IV trial across 1 site in France.
- Comparator
- Control group: patients with VAS < 4 treated surgically for endometriosis (infertility context); Test group: painful patients with VAS ≥ 4 treated surgically. Imaging comparator: MRI versus [18F]-FES PET/CT for lesion detection and characterization.
- Target Sample Size
- 20
Eligibility
Recruits 20 The trial does not select vulnerable populations. Patients under legal protection are explicitly excluded ("Patient under legal protection"). Participation requires informed consent from the adult patient (Age > 18 years old and "Patient with informed consent"). No assent procedures for minors are applicable because age >18 is required..
- Pregnancy Exclusion
- Pregnant patient
- Vulnerable Population
- The trial does not select vulnerable populations. Patients under legal protection are explicitly excluded ("Patient under legal protection"). Participation requires informed consent from the adult patient (Age > 18 years old and "Patient with informed consent"). No assent procedures for minors are applicable because age >18 is required.
Inclusion criteria
- {"criterion_text":"- Test: Painful patients with VAS ≥ 4 treated surgically for painful symptoms related to endometriosis"}
- {"criterion_text":"- Control: Patient with VAS < 4 treated surgically for endometriosis in the context of infertility"}
- {"criterion_text":"- Age > 18 years old"}
- {"criterion_text":"- Patient with informed consent"}
- {"criterion_text":"- Patients with preoperative MRI not contraindicated for [18F]-FES PET/CT"}
- {"criterion_text":"- Patient operated on mid-cycle"}
- {"criterion_text":"- Membership of a Social Security scheme"}
Exclusion criteria
- {"criterion_text":"- Patient treated for endometriosis without surgery"}
- {"criterion_text":"- Pregnant patient"}
- {"criterion_text":"- Claustrophobic patient"}
- {"criterion_text":"- Hypersensitivity to the active substance (Fluoroestradiol(18F)) or to one of the excipients"}
- {"criterion_text":"- Patient under legal protection"}
- {"criterion_text":"- Patient taking hormonal treatment"}
- {"criterion_text":"- Menopausal patient"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Characterization of the hypermetabolism of lesions on PET by analysis of SUV: Hypermetabolism present or not and quantification","definition_or_measurement_approach":"Assessment by analysis of standardized uptake value (SUV) on [18F]-FES PET/CT to determine presence or absence of hypermetabolism and to quantify SUV intensity."}
Secondary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Immunohistochemistry and in situ hybridization analyses characterizing marker intensity and receptor type per lesion by anatomical location."}
- {"endpoint_text":"- 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)","definition_or_measurement_approach":"IHC and in situ hybridization to characterize markings (intensity, receptor type) aggregated per patient and correlated with pain score (VAS)."}
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Comparison of diagnostic sensitivity between [18F]-FES PET/CT and MRI for superficial and deep lesions, stratified by lesion location."}
- {"endpoint_text":"- Degree of association between [18F] SUV intensity and ER expression (IHC) and pain intensity (VAS)","definition_or_measurement_approach":"Statistical analysis of associations between [18F] SUV intensity, estrogen receptor expression measured by IHC, and pain intensity measured by VAS."}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 42
- Consent Approach
- Participation requires informed consent from the adult participant (Age > 18 years old). Subject information and informed consent form for adults are provided (documents: L1_SIS and ICF adultes). No assent documents for minors are applicable. Language of key trial materials includes French (translations provided for titles and protocol).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
France
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 43
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Chirurgie gynécologique
- Principal Investigator Name
- Ariane WEYL
- Principal Investigator Email
- weyl.a@chu-toulouse.fr
- Contact Person Name
- Ariane WEYL
- Contact Person Email
- weyl.a@chu-toulouse.fr
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Toulouse
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- EstroTep 500 MBq/mL, solution injectable
- Active Substance
- FLUOROESTRADIOL F-18
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Authorisation Status
- Marketing authorisation in France (marketingAuthNumber: 34009 550 243 0 9)
- Maximum Dose
- 280 MBq
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