EUCTR2013-003165-34-IT进行中（未招募）不适用
Peptide Receptor Radionuclide Therapy (PRRT) with Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in advanced gastro-entero-pancreatic Neuroendocrine Tumors, FDG-PET negative patients: a prospective phase II randomized study. - LUNET
IRCCS-IRST of Meldola0 个研究点开始时间: 2013年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age >18 years.
- •-Patients must have histologically or cytologically confirmation of GEP–NETand Ki 67 index <= 20%.
- •-Measurable disease according to RECIST 1.1.criteria
- •-advanced GEP–NET are elegible; patients must have progressive disease based on RECIST 1.1. criteria
- •-Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
- •-FDG PET negative (SUV less than 2.5)
- •-No previous oncological treatments within 4 weeks
- •-No previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow
- •- signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •- Ki 67 index > 20 %
- •- FDG PET positive at least in one documented lesion with a SUV more than 2.5
- •- Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow.
- •5.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究者
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