Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in tumour cellular redox status
研究概览
简要总结
Prospective single centre non-randomised exploratory observational study to measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.
详细描述
Study design: Prospective single centre non-randomised exploratory observational study.
Number of patients: 32 (16 head and neck cancer, 16 lung cancer).
Primary hypothesis: Changes in 18F-FSPG uptake predict treatment efficacy.
Primary objectives: To measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.
Secondary objectives: Characterise the uptake and pharmacokinetics of 18F-FSPG in NSCLC and HNSCC patients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Aged 16 or above
- •Histologically confirmed HNSCC or NSCLC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)
- •Willingness and ability to comply with scheduled study visits and tests
- •Confirmation of adequate function of all major organs and systems
排除标准
- •Pregnant or lactating women
- •Concomitant uncontrolled medical conditions
- •Participants likely to require palliative radiotherapy within the first 12 weeks of treatment
- •Prognosis less than 3 months
- •Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)
结局指标
主要结局
Changes in tumour cellular redox status
时间窗: 3 years
To measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.
次要结局
- 18F-FSPG kinetics(2 years)
- Correlation with histopathology and blood biomarkers(3 years)
- 18F-FSPG heterogeneity(3 years)