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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: Xiaohui Duan, Prof.; Phone Number: 13512762365; Email: duanxh5@mail.sysu.edu.cn
• Study Contact Backup: Name: Lingjie Yang; Phone Number: 15989036151; Email: yanglj53@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Xiaohui Duan, Prof.; Phone Number: 13512762365; Email: duanxh5@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients first diagnosed with HNSCC by pathological biopsy and proposed to receive preoperative neoadjuvant therapy at Sun Yat-sen Memorial Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive positive score	Comprehensive positive score for PD-L1 expression	1 week before neoadjuvant therapy
Pathological response	Postoperative pathological tumor residual status	1 month after the last neoadjuvant therapy
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Neoadjuvant therapy; Programmed death-ligand 1; Head and neck squamous cell Carcinoma; Temporal diffusion spectroscopy imaging
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: SYSKY-2023-498-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No