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

NCT ID: NCT05964595

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma Magnetic Resonance Imaging Neoadjuvant Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaohui Duan, Prof.

Role: CONTACT

13512762365

Lingjie Yang

Role: CONTACT

15989036151

Facility Contacts

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Xiaohui Duan, Prof.

Role: primary

13512762365

Other Identifiers

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SYSKY-2023-498-01

Identifier Type: -

Identifier Source: org_study_id

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