Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IVIM Imaging MRF Imaging.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study on Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
Overview
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
- Device IVIM Imaging MRF Imaging
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 thr
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06751381 · ShuiBinJuan-2024-NPC001