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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06792526
Enrollment
20
Registered
2025-01-24
Start date
2025-01-20
Completion date
2025-08-20
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

Sponsors

Hainan People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. 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.

Design outcomes

Primary

MeasureTime frameDescription
Quantitative assessment of salivary gland changes using IVIM and MRF imagingFrom baseline to 3 months post-radiotherapyIVIM 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.

Contacts

Primary Contact蔚 吴
ww1538067425@outlook.com15689030575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026