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

March 3, 2025 updated by: Zilong Yuan

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Hubei Cancer Hospitla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study comprehensively reviewed the clinical information of OSCC patients who underwent NACI at two institutions from March 2020 to December 2023.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 2024 to 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zilong Yuan

Collaborators

Hubei Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2024]KYLL(SO4)
  • no. 2025HBCHHHRC006 (Other Grant/Funding Number: Yuan Wu)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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