Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- the mean received radiation dose to salivary glands (Dmean), and the total uptake of PSMA in salivary glands (SUVtotal) and its relative reduction after radiotherapy (ΔSUVtotal-6).
研究概览
简要总结
Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck.
详细描述
Primary objective of this prospective observational study is to determine the gland-based dose-effect relation between conventionally fractionated radiotherapy (RT) and long-term loss of acinar cells, per salivary gland type. The study population consists of a maximum of 20 patients with HNSCC referred for high-dose (CC)RT. There is no therapeutic intervention. Diagnostic intervention is PSMA PET/CT.
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
- 否
入选标准
- •HNSCC of the head-neck area, cTx-4 N0-3 M0
- •Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.
排除标准
- •Age <18y
- •Pregnancy or lactation
- •Participation in conflicting studies, e.g. with non-standard treatment and/or imaging
- •Inability to provide informed consent
结局指标
主要结局
the mean received radiation dose to salivary glands (Dmean), and the total uptake of PSMA in salivary glands (SUVtotal) and its relative reduction after radiotherapy (ΔSUVtotal-6).
时间窗: 6 months
Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation.
次要结局
- ΔSUV(1 month)
- voxel-based ΔSUV(7 weeks of treatment, follow-up 1 and 6 months)
- Voxel-based received radiation dose(7 weeks of treatment, 1 and 6 months)
- the clinical evaluation of a dry mouth(before treatment, once a week during 7 weeks of treatment and follow up 6 months after)