Evaluation of Positron Emission Tomography with Fludeoxyglucose (18F) for Preoperative Assessment of Endometriosis Lesions in Symptomatic Patients
- Trial ID
- 2024-520423-88-00
- Protocol
- 2013/CHU/12
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to assess the efficacy of **PET (positron emission tomography) scans** in diagnosing endometriosis lesions compared to surgical findings. This evaluation focuses on the number and locations of lesions diagnosed, which is clinically relevant as it may enhance preoperative planning and improve patient outcomes by providing a non-invasive diagnostic alternative.
Secondary objectives include:
- Comparing the sensitivity of **PET scanner** and MRI in detecting endometriosis lesions, which could inform the choice of imaging modality for better diagnostic accuracy.
- Defining a reading threshold of **SUV (Standardized Uptake Value)** on a PET scanner for diagnosing endometriosis, potentially standardizing diagnostic criteria and improving diagnostic consistency.
Participants
The clinical trial focuses on evaluating the effectiveness of PET scans in diagnosing **endometriosis** lesions compared to surgical methods. The study population consists exclusively of female participants, aged between 18 and 50 years, who are experiencing symptomatic endometriosis with a surgical indication. Participants must have at least one typical endometriosis lesion on MRI, greater than 5mm, and must consent to surgical management. The trial does not include male subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. Participants are required to be affiliates or beneficiaries of a social security scheme. The selection criteria ensure that the study population is representative of individuals who are likely to benefit from the diagnostic evaluation being assessed. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy of **PET (positron emission tomography)** scans in the preoperative assessment of symptomatic **endometriosis** lesions. This study is a randomized, double-blind, controlled trial, categorized as a confirmatory phase III trial. The trial is expected to commence recruitment on December 12, 2023, and conclude by December 12, 2025. Participants will be involved in the study for a maximum treatment period of one day, with the primary objective being the comparison of the number and location of endometriosis lesions diagnosed by PET scans versus those identified during surgery.
The trial will include several study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age (18-50 years), symptomatic endometriosis with surgical indication, and the presence of at least one typical lesion on MRI. Participants must also provide informed consent and be affiliated with a social security scheme. Follow-up visits will be scheduled to monitor the administration of the investigational products, which include **Furosemide**, **Fludeoxyglucose (18F)**, and **Iohexol**, all administered via intravenous injection. The end-of-study visit will evaluate the primary and secondary endpoints, including the total number of lesions diagnosed by PET scans and the SUV threshold for lesion identification.
Participant involvement is expected to last for the duration of the treatment period, with conditions for early termination including withdrawal of consent or adverse events that compromise participant safety. The trial's primary endpoints focus on the diagnostic accuracy of PET scans compared to surgical findings, while secondary endpoints explore the visibility of lesions on PET scans versus MRI. The study aims to provide valuable insights into the role of PET scans in the management of endometriosis, potentially influencing future diagnostic protocols.
Treatment
The clinical trial involves the administration of **Furosemide**, a diuretic agent, in the form of a **solution for injection**. The pharmaceutical formulation is provided as a 10 mg/ml concentration, and the administration route is **intravenous**. The maximum daily and total dose is 20 mg, with a treatment period limited to one day. The product is manufactured by Hameln Pharma Ltd and is not a pediatric formulation. Participant compliance with the dosing schedule will be monitored throughout the trial.
Another experimental medication used in the trial is **GLUCOTRACE**, which contains the active substance **Fludeoxyglucose (18F)**. This radiopharmaceutical is provided as a 185 MBq/ml **solution injectable** and is administered via **intravenous injection**. The maximum dose is 3 MBq/kg, with a treatment period of one day. The product is manufactured by Nucleis SA and is not intended for pediatric use. Compliance with the administration protocol will be closely monitored.
The trial also utilizes **Omnipaque**, containing the active substance **Iohexol**, as an auxiliary agent. This contrast medium is provided as a 350 mg I/ml **solution for injection**. The administration route is **injection**, with a maximum dose of 2 ml/kg, and the treatment period is restricted to one day. The product is manufactured by GE Healthcare BV and is not a pediatric formulation. Participant adherence to the dosing regimen will be ensured through systematic monitoring.
No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified for this clinical trial. The focus remains on the evaluation of the experimental medications and their role in the preoperative assessment of symptomatic endometriosis lesions.
Efficacy
The efficacy of the clinical trial titled "Contribution of PET (positron emission tomography) scans for the preoperative assessment of symptomatic endometriosis lesions: TEP-ENDORUN" will be assessed using specific primary and secondary endpoints. The primary endpoints include the total number of **endometriosis** lesions diagnosed by PET scan compared with the number of lesions described during surgery, as well as the number of locations identified by PET scan compared with those identified during surgery. These endpoints aim to evaluate the diagnostic accuracy of PET scans in identifying endometriosis lesions and their locations.
Secondary endpoints will focus on determining the SUV (Standardized Uptake Value) threshold necessary to identify endometriosis lesions. Additionally, the trial will assess the number of lesions visible on PET scan but not on MRI, and compare their locations as identified by PET scan versus MRI. These secondary endpoints are designed to further explore the diagnostic capabilities of PET scans in comparison to MRI.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patient aged over 18 and under 50
- Patient with symptomatic endometriosis with indication for surgery
- Patient showing at least one typical endometriosis lesion on MRI, greater than 5mm
- Patient accepting surgical management
- Patient having signed an informed consent after information
- Patient 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 with contraindication to surgery or anesthesia
- Patient unable to understand the interest of the study
- 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.)
- 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)
- Positive plasma HCG assay in the days preceding the PET scan;
- 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
- Blood glucose > 1.6 g/L e on day of PET Scanner
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Recruiting | 12 Dec 2023 | 15 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Furosemide 10 mg/ml solution for injection | Other | SOLUTION FOR INJECTION | INTRAVENOUS | 20 | 1 | PRD10403773 |
GLUCOTRACE 185 MBq/ml solution injectable | Test | SOLUTION INJECTABLE | INTRAVENOUS INJECTION | 3 | 1 | PRD4280355 |
Omnipaque 350 mg I/ml Injektionslösung | Other | INJEKTIONSLÖSUNG | INJECTION | 2 | 1 | PRD10001501 |