Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06751381
Enrollment
45
Registered
2024-12-27
Start date
2025-01-20
Completion date
2026-12-06
Last updated
2025-01-14

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

Conditions

Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

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.

Detailed description

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.

Interventions

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.

Sponsors

Hainan Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma. 2. Scheduled to undergo radiotherapy as part of standard treatment. 3. Aged 18 years or older. 4. No contraindications to MRI scans (e.g., no implanted metallic devices). 5. Written informed consent has been provided.

Exclusion criteria

1. Contraindications to MRI, such as metallic implants or claustrophobia. 2. Severe comorbid conditions, including significant renal or hepatic dysfunction. 3. Concurrent participation in another interventional clinical trial. 4. Pregnant or breastfeeding. 5. Any condition that may impair compliance with study procedures.

Design outcomes

Primary

MeasureTime frameDescription
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 reFrom baseline to 6 months post-radiotherapyIVIM 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.

Contacts

Primary ContactBinjuan Shui
3131683430@qq.com+15256895038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026