NCT01747096已完成不适用
Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
研究概览
简要总结
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).
Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
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
- None
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
- •Age over 18 years
- •effective contraception or exclusion of pregnancy dosage of beta-HCG in women of childbearing age
- •Fortuitous discovery of suggestive tumors of TE-GEP with well documented conventional imaging (multiphase CT; MRI, US endoscopy) associated or not associated with clinical or biological signs of TE-GEP tumors (increase in tumor markers) OR
- •Histologically proven GEP-TE (WHO classification 2010 (26) well differentiated in the initial staging OR
- •Suspicion of recurrence or progression of well differentiated TE-GEP tumors on conventional imaging or laboratory tests (increase in tumor markers) OR
- •Clinical or biological syndrome strongly suggestive of digestive endocrine disease without identification of lesions with conventional imaging
- •Informed consent and patient's written
- •Affiliation to an insurance
排除标准
- •Multiple endocrine neoplasia
- •TE GEP tumor not differentiated
- •Pregnancy and lactation
- •Persons protected by law
- •Restlessness, inability to lie still hold at least 1 hour; Claustrophobia
- •Poor compliance predictable or inability to undergo medical test for geographical, social or psychological
- •Treatment with radiotherapy, chemotherapy or other antitumor treatment within 6 weeks of previous morphological and scintigraphic examinations. In case of treatment with somatostatin analogues delayed, scans will be performed 4 weeks after the last injection. However, a shorter period may be observed to avoid to do again the initial assessment exams.
- •malignancy except basal cell cancers and cancer in situ of the cervix
- •Contraindication of injection of a contrast agent necessary for the production of multiphase scanner.
- •Patients who had a CT scan without injection of contrast material can not participate in the study
研究组 & 干预措施
68-Ga-DOTANOC
Experimental
干预措施: 68-Ga-DOTANOC (Drug)
结局指标
主要结局
Detection of Gastroenteropancreatic Neuroendocrine Tumors lesions in the initial assessment or during the search of recurrence.
时间窗: 12 months
Reference to the gold standard (that will be obtained from the data of histology and / or follow-up imaging at least 12 months
次要结局
- Compare the diagnostic performance of PET / CT with 68Ga-DOTANOC with the standard process(12 months)
研究者
研究点 (5)
Loading locations...
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