Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis
报名条件（概要）
- 年龄：18 Years – 64 Years
- 性别：女性
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Belgium
药品与企业信息
A \[18F\]AlF-FAPI-74 PET/CT will be performed at UZ Leuven before the participant's planned laparoscopy. Participants are required to fast for 4 hours before tracer administration but water is allowed. An intravenous line will be placed and \[18F\]AlF-FAPI-74 will be administered in one bolus (3.5 MBq/kg). PET/CT acquisition will start after 60 minutes. The CT will be a low dose CT with oral contrast. If there are no contraindications, 20 mg Buscopan may be administered shortly before imaging to reduce bowel movement. Participants may optionally undergo an additional NeuroEXPLORER PET/CT scan on the same day after the same \[18F\]AlF-FAPI-74 administration, so no second tracer injection is required. Participants who start treatment with a GnRH (ant)agonist after their first scan may undergo a second \[18F\]AlF-FAPI-74 PET/CT to investigate changes in tracer uptake during hormonal treatment. Participants will be monitored for adverse events related to study procedures.
A \[18F\]AlF-FAPI-74 PET/CT will be performed at UZ Leuven before the participant's planned laparoscopy. Participants are required to fast for 4 hours before tracer administration but water is allowed. An intravenous line will be placed and \[18F\]AlF-FAPI-74 will be administered in one bolus (3.5 MBq/kg). PET/CT acquisition will start after 60 minutes. The CT will be a low dose CT with oral contrast. If there are no contraindications, 20 mg Buscopan may be administered shortly before imaging to reduce bowel movement. Participants may optionally undergo an additional NeuroEXPLORER PET/CT scan on the same day after the same \[18F\]AlF-FAPI-74 administration, so no second tracer injection is required. Participants will be monitored for adverse events related to study procedures.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
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 analysis. (iii) Optionally undergo an additional NeuroEXPLORER PET/CT scan after the same tracer injection. (iv) Optionally undergo a second \[18F\]AlF-FAPI-74 PET/CT if participants started gonadotropin-releasing hormone (GnRH) treatment after their first scan to investigate whether tracer uptake in endometriosis lesions changes during treatment.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Niloefar Ahmadi Bidakhvidiniloefar.ahmadibidakhvidi@uzleuven.be+3216343715
- Elena Lara Jimenezelena.larajimenez@uzleuven.be
研究中心联系方式
- UZ LeuvenLeuven，Belgium
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis ClinicalTrials.gov Identifier: NCT07876648 Sponsor: Universitaire Ziekenhuizen KU Leuven Investigational product: [18F]AlF-FAPI-74 PET/CT, [18F]AlF-FAPI-74 PET/CT About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis 试验编号：NCT07876648 申办方：Universitaire Ziekenhuizen KU Leuven 研究药物：[18F]AlF-FAPI-74 PET/CT、[18F]AlF-FAPI-74 PET/CT 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。