EUCTR2020-002951-39-IT进行中（未招募）1 期
A multicenter open-label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas - NETTER-P
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- •1. GEP-NET cohort: Presence of metastasized or locally advanced, inoperable (curative intent), histologically proven, G1 or G2 (Ki-67 index =20%), well differentiated GEP-NET.
- •PPGL cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven PPGL.
- •2. Patients from 12 to < 18 years of age at the time of enrollment.
- •3. Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake.
- •4. Performance status as determined by Karnofsky score = 50 or Lansky Play-Performance Scale score = 50.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Laboratory parameters:
- •Estimated creatinine clearance calculated by the Cockroft-Gault method < 70 mL/min
- •Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L; platelets <75x109/L.
- •Total bilirubin >3 x ULN for age.
- •Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
研究者
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