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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05964595

Enrollment

136

Registered

2023-07-28

Start date

2023-07-01

Completion date

2025-12-31

Last updated

2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactXiaohui Duan, Prof.

duanxh5@mail.sysu.edu.cn13512762365

Backup ContactLingjie Yang

yanglj53@mail2.sysu.edu.cn15989036151

Outcome results