NCT06482307尚未招募1 期
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Correlation between tumour uptake and expression
研究概览
简要总结
This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor [18F]-olaparib als potential tracer for imaging of tumour PARP expression by PET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients >18y, with biopsy-proven HPV-negative HNSCC, or patients >40y with HPV-positive HNSCC and high-risk features (i.e. > 10 smoke packs/year AND ≥N2b)
- •Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
- •Recent archival tumour tissue (<8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels
- •Presence of a tumour lesion ≥10 mm in diameter
- •ECOG performance status 0-2
- •Negative pregnancy test in women with childbearing potential
- •Life expectancy >3 months
- •Signed written informed consent and able to comply with the protocol
- •For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)
排除标准
- •Recent treatment with PARP inhibitors or other investigational therapies <30 days.
- •Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.
结局指标
主要结局
Correlation between tumour uptake and expression
时间窗: 12-18 months
Determine the correlation between tumour \[18F\]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).
Dosimetry assessment
时间窗: 6-12 months
Assess dosimetry, most optimal time point for imaging (Stage I), and safety of \[18F\]olaparib PET (Stage I + II)
次要结局
- Evaluation of changes in tumour uptake(12-18 months)
研究者
研究点 (2)
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