Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
研究概览
简要总结
According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.
详细描述
The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 ≥ 18 years;
- •Able to provide spoken and written informed consent for the trial;
- •Histopathological confirmed neuroendocrine tumor;
- •Fulfill the clinical criteria for PRRT;
- •At least one soft tissue lesion > 2 cm;
- •Aimed administered activity of 7400 MBq;
- •ECOG score (performance status) 0-2.
排除标准
- •Not possible to discontinue LA-SSA for 4-6 weeks;
- •Use of short-acting SSAs;
- •Pregnancy and lactating female patients;
- •Inability to comply to the study procedures;
- •Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).
研究组 & 干预措施
2A - LA-SSA injection 4-6 weeks before PRRT
In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.
干预措施: Somatostatin analog (Drug)
2B - LA-SSA injection 1-7 days before PRRT
In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.
干预措施: Somatostatin analog (Drug)
结局指标
主要结局
Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
时间窗: SPECT/CT after 4h, 24h, and 5-7 days post-injection
次要结局
- Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.(SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection)
- Effect of continued LA-SSA use on the tumor-to-background ratio.(SPECT/CT after 4h, 24h, and 5-7 days post-injection)
- Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.(Blood samples at 2h, 4h, 24h and 5-7 days post-injection)