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NCT Number: NCT06751381

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective study designed to investigate the application of intravoxel incoherent motion (IVIM) and magnetic resonance fingerprinting (MRF) imaging techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients after radiotherapy. The study aims to quantify and assess salivary gland function changes during and after radiotherapy using advanced imaging technologies, with the goal of identifying early imaging biomarkers associated with radiation-induced damage.

Patients diagnosed with NPC and receiving standard radiotherapy will be recruited. Imaging data will be acquired at three time points: prior to radiotherapy (baseline), during radiotherapy (mid-course), and after radiotherapy (post-treatment). IVIM and MRF sequences will be performed to collect data on salivary gland microstructure, perfusion, and relaxation properties. These parameters will be analyzed to detect early changes in salivary gland function and correlate them with the development of xerostomia.

This study is expected to provide valuable insights into the utility of IVIM and MRF imaging in predicting and monitoring radiation-induced salivary gland damage. The findings may facilitate early intervention strategies and contribute to personalized radiotherapy planning aimed at minimizing xerostomia risk in NPC patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

    Time frame: From baseline to 6 months post-radiotherapy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Binjuan Shui

CONTACT

[email protected]

+15256895038

Sponsors and collaborators

Lead sponsor

Hainan Medical College

Other

Registry information

Official study title

A Prospective Study on Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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