💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to learn whether \[18F\]AlF-FAPI-74 PET/CT can help detect endometriosis in adult women who are already scheduled for laparoscopy due to suspicion of deep infiltrating endometriosis or superficial peritoneal endometriosis. The main aims are: (i) How well does \[18F\]AlF-FAPI-74 PET/CT identify endometriosis lesions compared with findings during laparoscopy? (ii) Can PET/CT identify additional lesions that may not be seen on ultrasound or MRI? (iii) Can ultra-high-resolution NeuroEXPLORER PET/CT improve the detection of small lesions compared with standard PET/CT? Participants will: (i) Receive an intravenous injection of \[18F\]AlF-FAPI-74 followed by a PET/CT scan before their planned laparoscopy. (ii) Undergo their planned laparoscopy, during which PET findings will be compared with the surgical findings and where tissue is removed with laboratory ana
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📋 Eligibility rules (as published)
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.
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