Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma

August 28, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. It is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. It is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. MRI has good soft tissue resolution and is a common preoperative examination method. However, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. At present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on MRI image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. In this study, multi-sequence MRI was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with head and neck squamous cell carcinoma, who were treated in Sun Yat-sen Memorial Hospital between January 2020 and October 2023, were included and randomly allocated into a training set (n = 300) and an internal validation set (n = 150). Patients treated in Sun Yat-Sen University Cancer Centre, Shenshan Medical Centre, Memorial Hospital of Sun Yat-sen University and Huizhou First Hospital between January 2020 and April 2024, were assigned as an external validation set (n = 150) . Patients treated in Sun Yat-sen Memorial Hospital, Sun Yat-Sen University Cancer Centre, Shenshan Medical Centre, Memorial Hospital of Sun Yat-sen University and Huizhou First Hospital between October 2024 and June 2025, were assigned as an prospective validation set (n = 150) .

Description

Inclusion Criteria:

  • (a) patients pathologically diagnosed as head and neck squamous cell carcinoma;
  • (b) patients receiving two or three courses of neoadjuvant therapy (traditional chemotherapy plus PD-1 inhibitor);
  • (c) MR scan within 30 days before the first course of neoadjuvant therapy;
  • (d) patients undergoing radical surgical dissection following neoadjuvant therapy;
  • (e) complete clinical data available.

Exclusion Criteria:

  • (a) previous head and neck treatment history;
  • (b) obvious motion or metal artifacts on the MRI image;
  • (c) distant metastasis;
  • (d) concurrent malignancies.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HNSCC with NACI
HNSCC with neoadjuvant chemoimmunotherapy, following by radical sugery.
Diagnostic test: MRI-based radiomics-clinical model
Response to NACI was predicted using MRI-based radiomics-clinical model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the area under the receiver operating characteristic (AUROC) curves
Time Frame: 2021.1-2023.2
2021.1-2023.2

Collaborators and Investigators

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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 25, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-1175-02

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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