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

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964595
• Other study ID #: SYSKY-2023-498-01
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Xiaohui Duan, Prof.
• Phone: 13512762365
• Email: duanxh5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Magnetic Resonance Imaging
• Neoadjuvant Therapy
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive positive score	Comprehensive positive score for PD-L1 expression	1 week before neoadjuvant therapy
Primary	Pathological response	Postoperative pathological tumor residual status	1 month after the last neoadjuvant therapy
Primary	Change from maximum transverse tumor diameter after neoadjuvant therapy	Maximum transverse tumor diameter before and after neoadjuvant therapy	1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy