Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors.
研究概览
简要总结
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs.
This study proposes 68Gallium(68Ga)-DOTATOC positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the safety and sensitivity of 68Ga-DOTATOC PET/CT at detecting NETs and other tumors with over-expression of somatostatin receptors.
详细描述
Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using 18-Fluoride-Fluorodeoxyglucose (18F-FDG). The 68Ga-DOTATOC radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.
After providing informed written consent subjects will complete a medical history questionnaire.
Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 68Ga-DOTATOC. Twenty-four hours after 68Ga-DOTATOC administration the study coordinator will call the patient and see if they have experienced any adverse events during that time period and complete the adverse event questionnaire found in section 9.6.
Follow-up Assessments
The following information will be collected up to 3 years following the PET/CT scans:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects:
- •World health organization performance status 0-2
- •Able to provide written informed consent/assent (or consent by guardian for subjects <19 years)
- •Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 30 minutes and tolerating intravenous cannulation for injection.
- •Patients must require imaging for either staging or re-staging of:
- •Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning
- •Sympathoadrenal system tumors (phaeochromocytoma, paraganglioma, neuroblastoma, ganglioneuroma)
- •Medullary thyroid carcinoma
- •Pituitary adenoma
- •Medulloblastoma
- •Merkel cell carcinoma
- •Small-cell lung cancer (mainly primary tumors)
- •Meningioma
- •Or any other NET / with potential for overexpression of SSTR
排除标准
- •Pregnancy
- •Patients who are medically unstable ex: acute cardiac or respiratory distress, hypotensive
- •Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70cm).
结局指标
主要结局
Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors.
时间窗: 3 years
Determination of sensitivity of both exams when compared with pathology reports (if available) and compared with routine imaging (CT, MRI, Octreoscan™, US) if available and will be determined by confidence intervals using an exact binominal distribution by comparing the 68Ga-DOTATOC PET/CT with 18F-FDG and conventional imaging (if available). The gold standard for the detection of lesions will be established through a combination of: 1) pathology; 2) unequivocal correlative imaging results as assessed independently by 2 physicians; 3) disease progression of specific findings upon follow-up, up to three years from baseline examination; 4) a clearly unequivocal plurimetastatic pattern confirmed by any imaging modality at any of the involved sites; 5) response of lesions on subsequent imaging following therapy.
次要结局
- Number of participants with self-reported 68Ga-DOTATOC-related adverse event(24 hours)
- Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement.(1 hour)
- Total number of lesions per anatomic location identified by 68Ga-DOTATOC PET/CT(3 years)