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Prospective trial of [18F]AlF-FAPI-74 for PET imaging of fibroblast activation protein in patients with endometriosis
EU CTIS ID: 2026-525272-25-00
What this study is testing
The aim of this project is to evaluate the diagnostic performance of non-invasive [18F]AlF-FAPI-74 PET/CT compared to laparoscopy, which is the current standard-of-care, invasive examination to diagnose endometriosis, in patients with a suspicion of deep infiltrating endometriosis and/or superficial peritoneal endometriosis. Additional objectives related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_CIV-25-06-053398.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants eligible for inclusion in this Trial must meet all of the following criteria: DE (deep infiltrating endometriosis) cohort: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures. 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF). 3. At least one of the following: o 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. o Diagnostic suspicion of DE, defined as an ultrasound and/or MRI that shows lesions suspicious for DE. 4. Planned laparoscopy for suspected endometriosis.
- Participants eligible for inclusion in this Trial must meet all of the following criteria: SPE (superficial peritoneal endometriosis) cohort: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures. 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF). 3. At least one of the following: o 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. o Diagnostic suspicion of SPE, defined as an ultrasound and/or MRI that shows lesions suspicious for SPE. 4. Planned laparoscopy for suspected endometriosis.
You likely can't join if
- Participants eligible for this Trial must not meet any of the following criteria: DE cohort: 1. Prior abdominal surgery less than one year ago. 2. Female who is pregnant, breast-feeding or is of child-bearing potential and not using an adequate, highly effective contraceptive or no usage of contraception when sexually active are not accepted. 3. Participant is mentally or legally incapacitated, does not understand the study design or is not willing or capable to undergo all study-specific procedures. 4. 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. 5. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial. 6. 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. 7. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv. 8. Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.
- Participants eligible for this Trial must not meet any of the following criteria: SPE cohort: 1. Ultrasound and/or MRI with lesions suspicious of ovarian endometriosis and/or DE. 2. Clinical symptoms suspicious of ovarian endometriosis and/or DE, determined by a clinician who is an expert in endometriosis. 3. Prior abdominal surgery less than one year ago. 4. Female who is pregnant, breast-feeding or is of child-bearing potential and not using an adequate, highly effective contraceptive or no usage of contraception when sexually active are not accepted. 5. Participant is mentally or legally incapacitated, does not understand the study design or is not willing or capable to undergo all study-specific procedures. 6. 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. 7. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial. 8. 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. 9. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv. 10. Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.