跳至主要内容
临床试验/NCT02753569
NCT02753569已完成不适用

Imaging NSCLC Treatment Response to Immunotherapy: Relating Inflammatory Activity on 18FDG PET to Tumour Specific Measures From DW-MRI

Institute of Cancer Research, United Kingdom1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Changes in DW-MRI derived ADC

研究概览

简要总结

This feasibility study will aim to assess the potential for functional imaging biomarkers (18FDG PET-CT and DW-MRI) to differentiate immunotherapy induced inflammation, indicative of response from non-response in patients with stage IV non-small cell lung cancer (NSCLC).

详细描述

30 patients, recruited from within the PEAR Study (Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours) will be scanned both before and after receiving immunotherapy for NSCLC. Immunotherapy induced changes in tumour ADC on DW-MRI (a surrogate of apoptotic tumour cell death) will be compared with changes in near contemporaneous, anatomically co-registered 18FDG PET-CT SUV (a non-specific marker for GLUT expression and hence metabolic activity in both tumour and tumour infiltrating lymphocytes). For treatment response, an increase in ADC (reflecting apoptosis within the tumour) is expected, while 18FDG uptake is expected to decrease compared with baseline tumour uptake. In the presence of significant inflammatory cell recruitment, the investigators hypothesise a similar increase in ADC on DW-MRI but without associated reduction in 18FDG PET-CT SUV. Thus the relationship between the ADC change on DW-MRI and the 18FDG change should distinguish between response and non-response in the presence of inflammation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recruited to PEAR: Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours Study

排除标准

  • MRI incompatible metal implants
  • Claustrophobia

结局指标

主要结局

Changes in DW-MRI derived ADC

时间窗: Duration of Study - 2 year

Describing changes in DW-MRI derived ADC will provide data that may be used to differentiate immune mediated response from non-response in a future study of treatment responses following immunotherapy.

Changes in FDG PET/CT SUV

时间窗: Duration of Study - 2 year

Describing changes in 18FDG-PET SUV will provide data that may be used to differentiate immune mediated response from non-response in a future study of treatment responses following immunotherapy.

次要结局

  • Assess for differences in tumour volume using DW-MRI(Duration of Study - 2 year)
  • Assess for differences in tumour volume using 18FDG PET-CT(Duration of Study - 2 year)
  • Assess correlation between DW-MRI derived ADC and FDG PET/CT SUV(Duration of Study - 2 year)
  • Ability to predict progression free time and overall survival using DW-MRI ADC(Duration of Study - 2 year)
  • Ability to predict progression free time and overall survival using 18FDG SUV(Duration of Study - 2 year)

研究者

发起方
Institute of Cancer Research, United Kingdom
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nandita deSouza

Professor of Translational Imaging

Institute of Cancer Research, United Kingdom

研究点 (1)

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