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

NCT06755567 | Not Yet Recruiting

• 1 other identifier: SYSKY-2023-1175-02
• Study Type: observational
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head and Neck Cancer; Neoadjuvant Therapy; Immunotherapy; Chemotherapy; Pathologic Complete Response

Outcome Measures

Primary Outcomes (1)

• the area under the receiver operating characteristic (AUROC) curves

  2021.1-2023.2

Study Arms (1)

HNSCC with NACI

HNSCC with neoadjuvant chemoimmunotherapy, following by radical sugery.

Diagnostic Test: MRI-based radiomics-clinical model

Interventions

MRI-based radiomics-clinical model DIAGNOSTIC_TEST

Response to NACI was predicted using MRI-based radiomics-clinical model.

HNSCC with NACI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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) .

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lin

CONTACT

0086-020-34071439; linpliang3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: December 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 1, 2025

Record last verified: 2024-12