Evaluation of Safety, Pharmacokinetics, Distribution,Radiation Safety and Sensitivity/Specificity of PET/CT Imaging With 68Ga-NYM096 in Participants With IRM
A Phase I Study Assessing the Safety, Pharmacokinetics, Radioactivity Distribution,Radiation Safety and Preliminary Diagnostic Performance of 68Ga-NYM096 Injection in Participants With Indeterminate Renal Masses
研究概览
详细说明
This will be a prospective, open-label, single-center phase I study. Histological confirmation will serve as standard of truth, to assess sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), as well as accuracy of 68Ga-NYM096 PET/CT Imaging.
A total of 20~40 participants with IRM scheduled for surgical resection will be enrolled and assigned to two dose groups. Each participant will receive a single injection of the assigned dose; dose escalation within the same participant is not permitted. The study includes screening period, dosing/imaging period, safety follow-up visit, and surgery follow-up period.
研究类型
注册 (估计的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM096.
- Age ≥18 years at the time of signing the informed consent form;
- ECOG score 0-2;
- Life expectancy ≥6 months;
- Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing;
- Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures
Exclusion Criteria:
- A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
- Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer.
- Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.
- Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT.
- Received other investigational drugs before 68Ga-NYM096 PET/CT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer.
- Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance.
- Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus [HCV] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies).
- Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination.
- Other situations where the investigator considers the participant unsuitable for this study
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:⁶⁸Ga-NYM096 Injection
|
Using a syringe to withdraw 68Ga-NYM096 injection, the dose will be administered via an intravenous injection
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
大体时间:4 days
|
Incidence of abnormal laboratory test results, abnormal vital signs and ECG
|
4 days
|
合作者和调查者
调查人员
- 首席研究员:Li Huo, MD、Peking Union Medical College Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- G09601
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.