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

Hainan Medical College

Status: Not yet enrolling

Conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Treatments: Device: IVIM Imaging MRF Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT06751381

ShuiBinJuan-2024-NPC001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

45 participants in 1 patient group

Nasopharyngeal Carcinoma Patients

Treatment:

Device: IVIM Imaging MRF Imaging