Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization
报名条件(概要)
- 年龄:18 Years – 70 Years
- 性别:不限
- 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
China
药品与企业信息
其他名称:68Ga-HBED-CC-PEG6-exendin-4
Investigational GLP-1R-targeted radiopharmaceutical modified with a PEG6 linker. Synthesized under mild 50 °C, 5 min one-step radiolabeling without purification, with radiochemical purity \>95% for up to two half-lives. Intravenous dose 1-4 mCi for whole-body PET/CT. The first 3 enrolled subjects receive dynamic PET acquisition to calculate human pharmacokinetic profiles and internal organ radiation dosimetry. Preclinical data confirmed elevated pancreatic and insulinoma uptake and improved pancreas-to-kidney ratio compared with non-PEGylated reference tracer.
其他名称:68Ga-HBED-CC-exendin-4
Reference GLP-1R-targeted radiopharmaceutical without PEG6 modification, serving as the control agent for head-to-head comparison. Prepared via one-step mild radiolabeling with no purification needed. Intravenous injection of 1-4 mCi followed by standard static PET/CT, completed within 7 days before or after the investigational tracer scan in each subject. Exhibits relatively higher renal background uptake that may interfere with visualization of left peri-renal insulinoma lesions. No dynamic PET acquisition is performed for this reference tracer.
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)
This clinical research evaluates a new PET/CT imaging agent, \[68Ga\]Ga-HBED-CC-PEG6-exendin-4, for localizing insulinoma, a rare pancreatic tumor that causes severe low blood sugar. Insulinomas are often small and hard to detect with regular CT, ultrasound or standard PET scans. This new tracer targets GLP1R, a protein highly expressed on insulinoma cells, with polyethylene glycol (PEG6) modification to improve tumor uptake and image contrast compared with the earlier similar agent \[68Ga\]Ga-HBED-CC-exendin-4. The investigators plan to enroll 20 adult patients suspected of or confirmed to have insulinoma. All participants will receive two free PET/CT scans within one week: one with the new PEG6-modified tracer and one with the original tracer. The first 3 participants will also get dynamic PET scanning to analyze drug distribution and radiation dose in the human body. Within one month after imaging, patients will undergo surgery or biopsy to get pathological results, which serve as the gold standard to calculate and compare the diagnostic accuracy of the two tracers. All imaging procedures follow standard clinical protocols with safe, low radiation doses within national diagnostic limits. Minor possible risks include slight pain or mild allergic reaction at the injection site; rare side effects related to exendin-4 may occur at a rate below 5%, and the research team has full emergency management measures ready. Participants can withdraw from the study at any time without penalty. All scan fees are covered by the research project, and each subject will receive a formal imaging report for clinical reference. The findings of this trial will help develop a more accurate imaging tool to precisely locate insulinoma and guide surgical treatment.
适应症
主动联系研究团队
总联系人(申办方/研究总部)
- Yaping Luo, MDluoyaping@live.com86-10-69154717
中国/港澳台研究中心
- Peking Union Medical College HospitalBeijing,Beijing Municipality,China
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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: Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization ClinicalTrials.gov Identifier: NCT07808879 Sponsor: Peking Union Medical College Hospital Investigational product: [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT, [68Ga]Ga-HBED-CC-exendin-4 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:Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization 试验编号:NCT07808879 申办方:Peking Union Medical College Hospital 研究药物:[68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT、[68Ga]Ga-HBED-CC-exendin-4 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)。