跳至主要内容
临床试验/jRCT1030240546
jRCT1030240546招募中不适用

External radiation exposure to the families living with patients with neuroendocrine tumors receiving 177Lu-DOTATATE radiotherapy

Novartis Pharma K.K.0 个研究点目标入组 30 人开始时间: 2024年12月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
主要终点
cumulative external exposure dose

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18age old over 至 No limit(—)

入选标准

  • Inclusion criteria for patients:
  • Patients with NET receiving 177Lu-DOTATATE therapy at standard dose (7.4 GBq+-10%).
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
  • Patients must be living with one or more people (e.g., spouse, partner, child, flat mate etc.)
  • Patients must give written informed consent form to allow them and their family members to participate in the study.
  • Patients must be 18 years of age or older.
  • Inclusion criteria for study participants (family members):
  • Family members must provide written informed consent form to participate in the study.
  • Family members must be living with a patient undergoing 177Lu-DOTATATE radiation therapy.
  • Family members must be 18 years of age or older.
  • Family members should have normal cognitive function.

排除标准

  • Any patient/family member participating in another clinical trial or study.
  • Any patient/family member who is pregnant or lactating.
  • Any family member undergoing any radiotherapy or exposure to medical diagnostics.
  • Any family member who works in a radiation-related field (e.g.: HCPs, employees in radio pharma companies, etc.).

结局指标

主要结局

cumulative external exposure dose

时间窗: 14 days

To evaluate the cumulative external exposure dose of family members living with patients treated with 177Lu-DOTATATE radiotherapy

次要结局

  • cumulative external exposure dose(Day 1)
  • daily compliance
  • 177Lu-DOTATATE residual radio activity

研究者

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