Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics

NCT06751381 | Not Yet Recruiting

• 1 other identifier: ShuiBinJuan-2024-NPC001
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study aims to evaluate the role of intravoxel incoherent motion (IVIM) imaging and magnetic resonance fingerprinting (MRF) techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients undergoing radiotherapy. The study will recruit patients diagnosed with NPC who are receiving standard radiotherapy, and quantitative imaging data will be collected using IVIM and MRF techniques at multiple time points, including pre-treatment, during radiotherapy, and post-treatment. The primary objective is to analyze changes in salivary gland structure and function and to identify early imaging biomarkers indicative of radiation-induced injury. The findings are expected to provide new insights into the dynamic progression of salivary gland damage, establish predictive models for the risk of xerostomia, and guide the development of personalized therapeutic strategies to mitigate long-term complications.

Conditions

Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure • Title: Quantitative assessment of salivary gland changes using IVIM and MRF imaging • Time Frame: From baseline to 6 months post-radiotherapy • Description: Quantification of salivary gland microstructural, perfusion, and re

  IVIM Imaging: Quantification of salivary gland microstructural and perfusion changes using IVIM-derived parameters (D, D\*, f values) to evaluate radiotherapy-induced changes. MRF Imaging: Quantification of salivary gland relaxation properties using MRF-derived relaxation times (T1 and T2 mapping) to evaluate radiotherapy-induced changes. Unit of Measure: IVIM: D, D\*, f values MRF: T1 and T2 relaxation times Analysis: Changes in salivary gland microstructure and perfusion (IVIM parameters) as well as relaxation properties (MRF parameters) will be assessed separately from baseline to 6 months post-radiotherapy.

  From baseline to 6 months post-radiotherapy

Study Arms (1)

Nasopharyngeal Carcinoma Patients

Device: IVIM Imaging MRF Imaging

Interventions

IVIM Imaging MRF Imaging DEVICE

IVIM imaging will be performed to evaluate microstructural and perfusion changes in the salivary glands of nasopharyngeal carcinoma patients undergoing radiotherapy. This technique quantifies diffusion and perfusion parameters, providing insights into early tissue damage. MRF imaging will be used to quantify salivary gland tissue characteristics, including relaxation parameters (T1 and T2 mapping), to monitor radiotherapy-induced damage. The technique enables precise tissue characterization through multi-parametric MRI.

Nasopharyngeal Carcinoma Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (aged 18 years or older) with a confirmed diagnosis of nasopharyngeal carcinoma who are scheduled to undergo radiotherapy as part of standard treatment. Recruitment will occur at the Department of Radiotherapy, Hainan Provincial People's Hospital. Eligibility requires the ability to undergo MRI scans and the provision of informed consent.

You may qualify if:

• Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma.
• Scheduled to undergo radiotherapy as part of standard treatment.
• Aged 18 years or older.
• No contraindications to MRI scans (e.g., no implanted metallic devices).
• Written informed consent has been provided.

You may not qualify if:

• Contraindications to MRI, such as metallic implants or claustrophobia.
• Severe comorbid conditions, including significant renal or hepatic dysfunction.
• Concurrent participation in another interventional clinical trial.
• Pregnant or breastfeeding.
• Any condition that may impair compliance with study procedures.

Sponsors & Collaborators

• Hainan Medical College: lead

Central Study Contacts

Binjuan Shui

CONTACT

+15256895038; 3131683430@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Graduate Research)

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 27, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): December 6, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share