NCT03288597Unknown不适用
A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
Peking University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2017年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response
研究概览
简要总结
68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign written informed consent form
- •age ≥ 18 years
- •pathologically confirmed neuroendocrine, Ki67>=10%;
- •No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;
- •Unresectable disease;
- •At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
- •Predicted survival >=3 months;
- •Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
- •Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
排除标准
- •In the process of antitumor therapy with effective response;
- •Refuse to accept PET/CT;
- •Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
- •Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
结局指标
主要结局
The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response
时间窗: 3 years
次要结局
- Compare SUVmax, tumor/liver ratio as a prognostic marker(3 year)
- The correlation between positive rate and SUV of PET/CT and prognosis(3 year)
研究者
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University
研究点 (1)
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