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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05964595

Collaborator

(none)

136

Enrollment

Location

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma Magnetic Resonance Imaging Neoadjuvant Therapy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

136 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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