Clinical trial NCT06751381: Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
Official title: A Prospective Study on Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
Lead sponsor: Hainan Medical College
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From baseline to 6 months post-radiotherapy
Secondary outcomes:
Other outcomes:
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