DOTATOC PET/CT for Imaging NET Patients
关键词
抽象
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:
- Initiation of a new treatment
- Laboratory results and pathology reports
- Results of imaging studies
- Final clinical diagnosis by physician and relevant clinical notes
The study is expected to take approximately 4 years for accrual.
日期
| 最后验证: | 11/30/2019 |
| 首次提交: | 06/07/2018 |
| 提交的预估入学人数: | 06/27/2018 |
| 首次发布: | 07/10/2018 |
| 上次提交的更新: | 01/20/2020 |
| 最近更新发布: | 01/21/2020 |
| 实际学习开始日期: | 07/10/2018 |
| 预计主要完成日期: | 12/30/2023 |
| 预计完成日期: | 12/30/2026 |
状况或疾病
干预/治疗
Diagnostic Test: PET/CT Diagnostic Imaging
Diagnostic Test: PET/CT Diagnostic Imaging
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| PET/CT Diagnostic Imaging Each subject will have two PET/CT scans, one using 68Ga-DOTATOC and the other using 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. | Diagnostic Test: PET/CT Diagnostic Imaging Blood pressure, heart rate, and oxygen saturation levels will be recorded prior to the injection and at 5 - 15 minutes after injection.
Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
The subject will rest in a comfortable chair for 60 minutes. After this uptake phase, the blood pressure, heart rate, and oxygen saturation levels will be recorded again. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 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 Exclusion Criteria: - 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). |
结果
主要结果指标
1. Sensitivity of 68Ga-DOTATOC PET/CT in the diagnosis of SSTR positive tumors. [3 years]
次要成果指标
1. Number of participants with 68Ga-DOTATOC-related adverse events as assessed by abnormal vital sign measurement. [1 hour]
2. Number of participants with self-reported 68Ga-DOTATOC-related adverse event [24 hours]
3. Total number of lesions per anatomic location identified by 68Ga-DOTATOC PET/CT [3 years]
