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

NCT ID: NCT06755567

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-25
• Study Completion Date: 2028-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

HNSCC with NACI

HNSCC with neoadjuvant chemoimmunotherapy, following by radical sugery.

MRI-based radiomics-clinical model

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

MRI-based radiomics-clinical model

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lin

Role: CONTACT

linpliang3@mail.sysu.edu.cn

0086-020-34071439

Other Identifiers

SYSKY-2023-1175-02

Identifier Type: -

Identifier Source: org_study_id