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

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.

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Key information

Conditions

Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

IVIM Imaging MRF Imaging

Other

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.

Primary outcomes

Quantitative assessment of salivary gland changes using IVIM and MRF imaging

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

蔚吴

CONTACT

[email protected]

15689030575

Sponsors and collaborators

Lead sponsor

Hainan People's Hospital

Other

Registry information

Official study title

Monitoring Salivary Gland Damage After Radiotherapy in Patients with Head and Neck Cancer Using Multimodal Radiomics

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 24, 2025
Registry last updated: Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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