Study on the Use of PET Scans with Fludeoxyglucose (18F) for Diagnosing Endometriosis in Patients with Symptoms

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What is this study about?

This clinical trial is focused on studying the condition known as endometriosis, which is a painful disorder where tissue similar to the lining inside the uterus grows outside the uterus. The study aims to evaluate the effectiveness of a special type of scan called a positron emission tomography (PET) scan in identifying endometriosis lesions before surgery. The PET scan will be compared to the findings from surgery to see how well it can detect the number and location of these lesions.

During the study, participants will undergo a PET scan using a substance called fludeoxyglucose (18F), which helps highlight areas of concern in the body. This is a solution that is injected into the body and is designed to make the PET scan images clearer. The study will also use a solution called Furosemide, which is a medication that helps the body get rid of excess fluid, and Omnipaque, a contrast agent that improves the visibility of internal structures in imaging tests.

The purpose of the study is to determine if the PET scan can accurately diagnose endometriosis lesions compared to traditional surgical methods. Participants will receive these injections and undergo the PET scan, and the results will be compared to what is found during surgery. This research could help improve the way endometriosis is diagnosed and managed in the future.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying age, symptoms, and the presence of endometriosis lesions greater than 5mm on an MRI scan.

Eligibility criteria include being aged over 18 and under 50, having symptomatic endometriosis with an indication for surgery, and having signed an informed consent form.

2 preparation for PET scan

Preparation involves the administration of fludeoxyglucose (18f), a radioactive substance used in PET scans. This is given as an intravenous injection.

The purpose of this step is to enhance the visibility of endometriosis lesions during the PET scan.

3 PET scan procedure

A positron emission tomography (PET) scan is conducted to assess the number and location of endometriosis lesions.

The scan aims to provide detailed images that help in diagnosing endometriosis lesions compared to surgery.

4 administration of furosemide

Furosemide, a diuretic, is administered as a 10 mg/ml solution for injection. This is given intravenously to help clear the radioactive substance from the body after the PET scan.

5 administration of iohexol

Iohexol, a contrast agent, is administered as Omnipaque 350 mg I/ml solution for injection. This is used to enhance imaging results.

The injection is given intravenously to improve the clarity of the images obtained during the scan.

6 surgical assessment

Surgical assessment is conducted to compare the findings from the PET scan with the actual number and location of endometriosis lesions.

This step is crucial for evaluating the effectiveness of the PET scan in diagnosing endometriosis.

7 follow-up and analysis

Follow-up involves analyzing the data collected from the PET scan and surgical assessment.

The primary goal is to determine the total number of lesions diagnosed by the PET scan compared to surgery, and to identify any additional lesions visible on the PET scan but not on the MRI.

Who Can Join the Study?

Patient must be a woman aged over 18 and under 50.
Patient must have symptomatic endometriosis, which means experiencing symptoms of endometriosis, and must need surgery.
Patient must show at least one typical endometriosis lesion on an MRI scan, which is a special imaging test, and the lesion must be greater than 5mm in size.
Patient must agree to undergo surgical treatment.
Patient must have signed an informed consent, which means they have been given information about the study and agree to participate.
Patient must be affiliated with or a beneficiary of a social security scheme, which means they have some form of health insurance or coverage.

Who Cannot Join the Study?

Only females can participate in the study. Males are excluded.
Participants must be within a specific age range. If you are outside this range, you cannot join the study.
Individuals who are considered part of a vulnerable population are not allowed to participate. A vulnerable population includes people who might have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De La Reunion	St Denis	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	12.12.2023

Trial locations

Investigated drugs:

PET Scan is a type of imaging test that helps doctors see how the tissues and organs inside your body are functioning. In this trial, it is used to help diagnose endometriosis lesions by providing detailed images that can show the presence and location of these lesions before surgery.

Investigated diseases:

Endometriosis

Endometriosis – Endometriosis is a condition where tissue similar to the lining inside the uterus starts to grow outside the uterus. This misplaced tissue can be found on the ovaries, fallopian tubes, and the outer surface of the uterus, as well as other organs in the pelvis. The tissue behaves like normal uterine tissue, thickening, breaking down, and bleeding with each menstrual cycle. However, because it has no way to exit the body, it becomes trapped, leading to inflammation and the formation of scar tissue. Over time, this can cause pain, especially during menstruation, and may lead to fertility problems. The severity of symptoms can vary widely among individuals.

Trial ID:

2024-520423-88-00

Protocol code:

2013/CHU/12

NCT ID:

NCT04831619

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Use of PET Scans with Fludeoxyglucose (18F) for Diagnosing Endometriosis in Patients with Symptoms

What is this study about?

Who Can Join the Study?

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