NCT05964595招募中不适用
Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2023年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Comprehensive positive score
研究概览
简要总结
The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).
The main questions it aims to answer are:
- If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?
- If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy.
There is not a comparison group in our study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy
- •Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy
- •Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy
排除标准
- •Less than 10mm in the maximum diameter of the baseline primary tumor
- •Poor MRI image quality with obvious metal or motion artifacts
- •The failure to complete the course of neoadjuvant therapy
结局指标
主要结局
Comprehensive positive score
时间窗: 1 week before neoadjuvant therapy
Comprehensive positive score for PD-L1 expression
Pathological response
时间窗: 1 month after the last neoadjuvant therapy
Postoperative pathological tumor residual status
Change from maximum transverse tumor diameter after neoadjuvant therapy
时间窗: 1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy
Maximum transverse tumor diameter before and after neoadjuvant therapy
次要结局
未报告次要终点
研究者
研究点 (1)
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