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

NCT05964595 | Unknown

• 1 other identifier: SYSKY-2023-498-01
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Head and neck squamous cell Carcinoma; Temporal diffusion spectroscopy imaging; Programmed death-ligand 1; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Xiaohui Duan, Prof.

CONTACT

13512762365; duanxh5@mail.sysu.edu.cn

Lingjie Yang

CONTACT

15989036151; yanglj53@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 28, 2023
• Study Start: July 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)