68Ga-ICAM-1pep PET/CT Imaging of Tumor Responses to Radiotherapy in Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Quantitate the standardized uptake values (SUVs) of 68Ga-ICAM-1pep at baseline.
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-ICAM-1pep in metastatic cancer patients receiving radiotherapy. A single dose of 2.96 MBq/kg body weight of 68Ga-ICAM-1pep will be injected intravenously. The visual and semiquantitative methods will be used to assess the PET/CT images.
详细描述
Radiotherapy has a systemic inhibitory effect on non-irradiated lesions (abscopal effect) in addition to local antitumor effects, and currently no biomarkers are used for the prediction of the abscopal effect of radiotherapy in standard clinical practice. Our recent preclinical studies identified ICAM-1 as a potential predictive biomarker for the radiotherapy-induced abscopal effect. In this clinical trial, we aim to investigate whether the ICAM-1-targeting radiotracer 68Ga-ICAM-1pep could be used for PET imaging of tumor responses to radiotherapy in cancer patients. PET/CT imaging of 68Ga-ICAM-1pep will be performed in patients before and after radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old;
- •ECOG score 0 or 1 point;
- •Patients with suspected or confirmed lung cancer, esophagus cancer, cervical cancer or other cancers who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.
排除标准
- •Pregnant or nursing;
- •Severe hepatic or renal dysfunction;
- •Low WBC (less than 3 x 10^9/L);
- •Unable to comply with the PET/CT imaging procedures.
研究组 & 干预措施
68Ga-ICAM1-1pep PET/CT in cancer patients before radiotherapy
Cancer patients who have not undergone radiotherapy will be injected with 2.96 MBq/kg body weight of 68Ga-ICAM-1pep in one dose intravenously and then undergo PET/CT scan 1 h later.
Interventions:
Drug: 68Ga-ICAM-1pep Device: PET/CT
干预措施: 68Ga-ICAM-1pep (Drug)
68Ga-ICAM1-1pep PET/CT in cancer patients after radiotherapy
Cancer patients post-radiotherapy will be injected with 2.96 MBq/kg body weight of 68Ga-ICAM-1pep in one dose intravenously and then undergo PET/CT scan 1 h later.
Interventions:
Drug: 68Ga-ICAM-1pep Device: PET/CT
干预措施: 68Ga-ICAM-1pep (Drug)
结局指标
主要结局
Quantitate the standardized uptake values (SUVs) of 68Ga-ICAM-1pep at baseline.
时间窗: At baseline
Perform PET/CT imaging using 68Ga-ICAM-1pep before radiotherapy.The semiquantitative analysis will be performed by the same nuclear medicine physician for all cases, and the standardized uptake values (SUVs) of 68Ga-ICAM-1pep in the tumor lesions will be measured.
Characterize changes in the standardized uptake values (SUVs) of 68Ga-ICAM-1pep during radiotherapy.
时间窗: 3 to 4 weeks after beginning of radiotherapy
Perform PET/CT imaging using 68Ga-ICAM-1pep after radiotherapy. The semiquantitative analysis will be performed by the same nuclear medicine physician for all cases, and the standardized uptake values (SUVs) of 68Ga-ICAM-1pep in the tumor lesions will be measured. The SUVs of 68Ga-ICAM-1pep in the tumor lesions after radiotherapy will be compared with that at the baseline.
次要结局
未报告次要终点
研究者
Hua Zhu
Principal Investigator and Vice Director
Peking University Cancer Hospital & Institute