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Trial Title:
Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy
NCT ID:
NCT05964595
Condition:
Head and Neck Squamous Cell Carcinoma
Magnetic Resonance Imaging
Neoadjuvant Therapy
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Head and neck squamous cell Carcinoma
Temporal diffusion spectroscopy imaging
Programmed death-ligand 1
Neoadjuvant therapy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
The patients first diagnosed with HNSCC by pathological biopsy and proposed to receive
preoperative neoadjuvant therapy at Sun Yat-sen Memorial Hospital
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohui Duan, Prof.
Phone:
13512762365
Email:
duanxh5@mail.sysu.edu.cn
Start date:
July 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05964595
