2026-525272-25-00招募中2 期
Prospective trial of [18F]AlF-FAPI-74 for PET imaging of fibroblast activation protein in patients with endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Evaluation of the diagnostic performance of [18F]AlF-FAPI-74 PET/CT as a non-invasive tool to diagnose deep infiltrating endometriosis and/or superficial peritoneal endometriosis, in comparison with intra-operative laparoscopic findings (current gold-standard) in women with suspected endometriosis. The diagnostic performance is evaluated by correlating the locations of endometriotic lesions on [18F]AlF-FAPI-74 PET/CT and the locations of endometriotic lesions detected during laparoscopy.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants eligible for inclusion in this Trial must meet all of the following criteria: DE (deep infiltrating endometriosis) cohort:
- •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: 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.
- •Planned laparoscopy for suspected endometriosis.
- •Participants eligible for inclusion in this Trial must meet all of the following criteria: SPE (superficial peritoneal endometriosis) cohort:
- •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: 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.
- •Planned laparoscopy for suspected endometriosis.
排除标准
- •Participants eligible for this Trial must not meet any of the following criteria: DE cohort:
- •Prior abdominal surgery less than one year ago.
- •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.
- •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.
- •Participants eligible for this Trial must not meet any of the following criteria: SPE cohort:
- •Ultrasound and/or MRI with lesions suspicious of ovarian endometriosis and/or DE.
- •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, 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.
- •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.
研究组 & 干预措施
Buscopan 20 mg/1 ml oplossing voor injectie
Auxiliary
干预措施: Buscopan 20 mg/1 ml oplossing voor injectie (Drug)
结局指标
主要结局
Evaluation of the diagnostic performance of [18F]AlF-FAPI-74 PET/CT as a non-invasive tool to diagnose deep infiltrating endometriosis and/or superficial peritoneal endometriosis, in comparison with intra-operative laparoscopic findings (current gold-standard) in women with suspected endometriosis. The diagnostic performance is evaluated by correlating the locations of endometriotic lesions on [18F]AlF-FAPI-74 PET/CT and the locations of endometriotic lesions detected during laparoscopy.
Evaluation of the diagnostic performance of [18F]AlF-FAPI-74 PET/CT as a non-invasive tool to diagnose deep infiltrating endometriosis and/or superficial peritoneal endometriosis, in comparison with intra-operative laparoscopic findings (current gold-standard) in women with suspected endometriosis. The diagnostic performance is evaluated by correlating the locations of endometriotic lesions on [18F]AlF-FAPI-74 PET/CT and the locations of endometriotic lesions detected during laparoscopy.
Additional primary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_CIV-25-06-053398.
Additional primary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_CIV-25-06-053398.
次要结局
- Sensitivity, specificity, positive predictive value, negative predictive value, accuracy of [18F]AlF-FAPI-74 PET/CT in detecting endometriotic lesions.
- Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of endometriotic lesions on [18F]AlF-FAPI-74 PET/CT.
- Endometriotic lesion-to-background uptake values (SUV lesion divided by SUV background) for [18F]AlF-FAPI-74 PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake).
- Total FAP-positive endometriotic burden, defined as the sum of the volumes of all lesions deemed to be endometriotic in nature.
- Number of additional endometriotic lesions recorded after unblinding of the surgeon during laparoscopy.
- Diagnostic performance of MRI in detecting endometriotic lesions, in patients in which MRI is available, and comparison with [18F]AlF-FAPI-74 PET/CT, laparoscopy and if available ultrasound.
- Diagnostic performance of ultrasound in detecting endometriotic lesions, in patients in which ultrasound is available, and comparison with [ 18F]AlF-FAPI-74 PET/CT, laparoscopy and if available MRI.
- Impact on clinical management.
- Psychological impact on patient of [18F]AlF-FAPI-74 PET/CT procedure.
- Intra- and interobserver reproducibility of [18F]AlF-FAPI-74 PET/CT.
- Patient safety: adverse events of [18F]AlF-FAPI-74 PET/CT.
- Correlation of [18F]AlF-FAPI-74 biodistribution with FAP tissue expression as measured by immunohistochemistry (IHC).
- Evolution of [18F]AlF-FAPI-74 PET/CT scans in patients initiating GnRH-agonist or GnRH-antagonist medication and receiving 2 [18F]AlF-FAPI-74 PET/CT (prior and post initiation of GnRH-agonist or GnRH-antagonist medication) : (i) number of lesion; (ii) uptake; (iii) endometriotic lesion-to-background value; (iv) correlation with laparoscopy and if available MRI and/or ultrasound.
- Additional secondary endpoints related to the clinical investigational NeuroEXPLORER device: See Master Protocol EUDAMED_CIV-25-06-053398.
研究者
Niloefar Ahmadi Bidakhvidi
Scientific
UZ Leuven
研究点 (1)
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