Imaging endometriosis with a special PET tracer in adult women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective imaging study evaluates the use of [18F]AlF-FAPI-74 PET/CT to detect endometriosis before laparoscopic surgery in adult women. Participants receive the tracer, then undergo PET/CT followed by planned laparoscopy, with surgical findings and tissue analysis used for comparison. An optional NeuroEXPLORER high-resolution PET/CT may be performed after the same tracer dose to see if smaller lesions can be identified. The study aims to determine how well the tracer identifies lesions seen during surgery and whether it reveals additional lesions beyond ultrasound or MRI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary written informed consent of the participant has been obtained prior to any screening procedures.
* At least 18 years of age at the time of signing the Informed Consent Form (ICF).
* At least one of the following to be eligible for the DE cohort: (i) Clinical suspicion of DE, defined as the presence of deep nodule(s) during vaginal examination determined by a clinician who is an expert in endometriosis. (ii) Diagnostic suspicion of DE, defined as an ultrasound and/or MRI that shows lesions suspicious for DE.
* At least one of the following to be eligible for the SPE cohort: (i) Clinical suspicion of SPE, defined as clinical symptoms suspicious of SPE determined by a clinician who is an expert in endometriosis. These clinical symptoms include dysmenorrhea, deep dyspareunia, dysuria, dyschezia, painful rectal bleeding or haematuria, shoulder tip pain, catamenial pneumothorax, cyclical cough/haemoptysis/chest pain, cyclical scar swelling and pain, fatigue, and infertility. (ii) Diagnostic suspicion of SPE, defined as an ultrasound and/or MRI that shows lesions suspicious for SPE.
* Planned laparoscopy for suspected endometriosis.

Exclusion Criteria:

* For SPE cohort: (i) Ultrasound and/or MRI with lesions suspicious of ovarian endometriosis and/or DE. (ii) Clinical symptoms suspicious of ovarian endometriosis and/or DE, determined by a clinician who is an expert in endometriosis.
* Prior abdominal surgery less than one year ago.
* Female who is pregnant, breastfeeding or is of childbearing potential and not using an adequate, highly effective contraceptive or no usage of contraception when sexually active are not accepted.
* Participant is mentally or legally incapacitated, does not understand the study design or is not willing or capable to undergo all study-specific procedures.
* Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol, or may influence the result of the study.
* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
* Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
* Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
* Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Niloefar Ahmadi Bidakhvidi
• Email: niloefar.ahmadibidakhvidi@uzleuven.be
• Phone: +3216343715

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

  Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07816133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.