Prospective Study on Monitoring Parotid Gland Injury After Radiotherapy for Head and Neck Tumors Using Multimodal Radiomics

Not yet recruiting

• Conditions: Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer

• Registration Number: NCT06792526
• Lead Sponsor: Hainan People's Hospital

Brief Summary

Exploring a non-invasive and objective method for ultra early quantitative assessment of radiation-induced parotid gland injury. To provide a new and early method for evaluating changes in parotid gland function in clinical practice, and to guide the timing of interventions to protect the parotid gland.

Detailed Description

Exploring the application value of magnetic resonance fingerprinting (MRF) and intravoxel incoherent motion (IVIM) techniques in dynamically monitoring parotid gland injury and predicting the risk of dry mouth after radiotherapy for head and neck tumors. The study evaluated the changes in parotid gland cell density and microcirculation function by quantifying MRF (T1/T2 relaxation time, proton density) and IVIM parameters (D value, D \* value, f value), combined with parotid gland volume reduction rate, to establish an early risk model for predicting dry mouth syndrome and optimize parotid gland protection strategies.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-12
• Study Start: 2025-01-20
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-07-20
• Study Completion: 2025-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative assessment of salivary gland changes using IVIM and MRF imaging	From baseline to 3 months post-radiotherapy	IVIM imaging will be performed to evaluate microstructural and perfusion changes in the salivary glands of Head and Neck Cancer 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.