Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of PET imaging
研究概览
简要总结
Through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. The investigators propose in this project to develop on their site, the radiosynthesis of 68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging OctreoScan®. The objectives of this project are: - to validate the radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years
- •Patient who is suspected of endocrine tumors according to symptomatology, biology or imaging or pathological context (multiple endocrine neoplasia type 1)
- •initial staging: this includes research multifocal disease or locoregional or metastatic extension if well-differentiated neuroendocrine tumor (grade 1 et/ou 2)
- •Search of the primary tumor, especially in the case of the inaugural discovery of metastases
- •staging of a known recurrence
- •Search occult recurrence or suspicion of recurrence (clinical, laboratory, imaging doubtful)
- •Patient who have received in a lower range than 2 months of cervico-thoraco-abdominal-pelvic CT and scintigraphy in OctréoScan®
- •Patient who have signed an informed consent
- •Patient affiliated or beneficiary of regime of social security of a Member State of the European community
排除标准
- •Patient with another evolutive cancer disease and/or treated for less than 5 years
- •Pregnant or lactating woman
- •Premenopausal woman without effective contraception (estrogen-progestin or intrauterine contraceptive device)
- •Patient unable to give their free and informed consent
- •Persons placed under judicial protection
研究组 & 干预措施
Patient who is suspected of endocrine tumors
According to symptomatology, biology or imaging or pathological context
干预措施: 68Ga-DOTATOC PET-CT Imaging (Procedure)
结局指标
主要结局
Evaluation of PET imaging
时间窗: Inclusion (day 0)
The diagnostic performance of PET-CT will be calculated and compared with other standard exams as the gold standard histology and clinical follow-up.
次要结局
- Impact on the therapeutic management(End of follow up (day 28))
- Reproducibility(Inclusion (day 0))
- Tolerance(Inclusion (day 0) and until end of follow up (day 28))