Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Neoadjuvant Therapy; Magnetic Resonance Imaging

• Registration Number: NCT05964595
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).

The main questions it aims to answer are:

* If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?

* If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy.

There is not a comparison group in our study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-21
• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy
• Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy
• Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy

Exclusion Criteria

• Less than 10mm in the maximum diameter of the baseline primary tumor
• Poor MRI image quality with obvious metal or motion artifacts
• The failure to complete the course of neoadjuvant therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comprehensive positive score	1 week before neoadjuvant therapy	Comprehensive positive score for PD-L1 expression
Pathological response	1 month after the last neoadjuvant therapy	Postoperative pathological tumor residual status
Change from maximum transverse tumor diameter after neoadjuvant therapy	1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy	Maximum transverse tumor diameter before and after neoadjuvant therapy

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China