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临床试验/NCT06854107
NCT06854107已完成不适用

Intratumoral and Peritumoral Habitat Radiomics of MRI Predict Pathologic Complete Response to Neoadjuvant Chemoimmunotherapy in Oral Squamous Cell Carcinoma

Zilong Yuan1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2023年12月1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
225
试验地点
1
主要终点
Intratumoral and Peritumoral Habitat Radiomics of MRI predicts pathologic complete response to neoadjuvant chemoimmunotherapy in oral squamous cell carcinoma

研究概览

简要总结

Background:Neoadjuvant chemoimmunotherapy (NACI) shows promise in oral squamous cell carcinoma (OSCC), but reliable noninvasive biomarkers for predicting pathologic complete response (pCR) remain scarce. Radiomics integrating intratumoral and peritumoral heterogeneity across multi-sequence MRI may offer novel insights into treatment response evaluation.

Methods: The data of 212 patients with OSCC after NACI were retrospectively collected and analyzed. Among these patients, 56 (26.4%) achieved pCR after NACI. Intratumoral and peritumoral habitat imaging (HI) was achieved using the K-means clustering algorithm applied to T1-weighted imaging (T1WI), axial T2-weighted imaging with fat suppression (T2WI), and contrast-enhanced T1-weighted imaging with fat suppression (T1C). Moreover, intratumoral and peritumoral HI models were constructed and compared using the receiver operating characteristic (ROC) curve. Five-fold cross-validation was performed to mitigate model overfitting.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Histopathologically confirmed OSCC at the initial diagnosis;
  • •No treatment received prior to the first MRI examination;
  • •Receipt of NACI;
  • •Underwent MRI examination after NACI;
  • •Underwent surgical intervention.

排除标准

  • •Absence of clinical data and postoperative pathological results;
  • •MRI image artifacts significantly affecting image quality.

结局指标

主要结局

Intratumoral and Peritumoral Habitat Radiomics of MRI predicts pathologic complete response to neoadjuvant chemoimmunotherapy in oral squamous cell carcinoma

时间窗: From 2024 to 2025

Integrated intratumoral and peritumoral HI derived from multi-sequence MRI offers a high predictive capacity for pCR following NACI in OSCC patients.

次要结局

未报告次要终点

研究者

发起方
Zilong Yuan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zilong Yuan

Clinical Professor

Hubei Cancer Hospital

研究点 (1)

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