Trop2-targeted immunoPET Imaging of Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Radiation dosimetry of tissues/organs
研究概览
简要总结
This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.
详细描述
Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.For patients with prostate cancer or suspected prostate cancer, head-to-head comparisons with PSMA PET are still needed.
Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.
Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 year-old and of either sex
- •Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;
- •Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.
排除标准
- •Pregnancy；
- •Severe hepatic and renal insufficiency;
- •Allergic to single-domain antibody radiopharmaceuticals.
研究组 & 干预措施
Trop2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-T4 (Drug)
Trop2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-RT4 (Drug)
Trop2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-T4 (Drug)
Trop2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-RT4 (Drug)
结局指标
主要结局
Radiation dosimetry of tissues/organs
时间窗: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of tumors
时间窗: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of whole-body
时间窗: 1 day from injection of the tracers
Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Diagnostic sensitivity
时间窗: 30 days
Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Diagnostic specificity
时间窗: 30 days
Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Accuracy
时间窗: 30 days
Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Positive Predictive Value (PPV)
时间窗: 30 days
PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Negative Predictive Value (NPV)
时间窗: 30 days
NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
时间窗: 1 day from injection of the tracers
Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
SUV of tumors
时间窗: 1 day from injection of the tracers
The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
次要结局
- Trop2 immunoPET/CT in altering initial staging for patients with solid tumors(3-6 months)
- Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors(3-6 months)
- Trop2 immunoPET/CT for restaging for patients with solid tumors(3-6 months)
- Trop2 immunoPET/CT in evaluating treatment responses(1-2 years)