Skip to main content
OpenTrials
Completed

NCT Number: NCT06854107

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pathologic Complete Response Carcinoma Carcinoma, Squamous Cell Disease Attributes Disease Progression Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Squamous Cell Carcinoma of Head and Neck

Sex eligibility

All sexes

Study type

Observational

Primary location

Hubei Cancer Hospitla

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zilong Yuan

Other

Collaborators

  • Hubei Cancer Hospital

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.