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Not yet recruiting NCT06792526

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

Observational Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer

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: Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer. 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 →
Official title

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

Overview

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.

Interventions

  • Other IVIM Imaging MRF Imaging
    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-par

Primary outcome measures

  • Quantitative assessment of salivary gland changes using IVIM and MRF imaging [Time frame: From baseline to 3 months post-radiotherapy]

Eligibility criteria

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.

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: NCT06792526 · WuWei-2025-NPC002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗