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

NCT06792526 | Not Yet Recruiting

• 1 other identifier: WuWei-2025-NPC002
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Quantitative assessment of salivary gland changes using IVIM and 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-parametric MRI.

  From baseline to 3 months post-radiotherapy

Study Arms (1)

Head and Neck Cancer

Other: IVIM Imaging MRF Imaging

Interventions

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.

Head and Neck Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (18 years of age or older) who have been diagnosed with a head and neck tumour and are planning to receive radiotherapy as part of their standard treatment. Recruitment will take place at the Department of Radiotherapy, Hainan Provincial People's Hospital. Applicants must be able to undergo an MRI scan and provide informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hainan People's Hospital: lead

MeSH Terms

Conditions

Xerostomia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Central Study Contacts

蔚 吴

CONTACT

15689030575; ww1538067425@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Graduate Research)

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 24, 2025
• Study Start: January 20, 2025
• Primary Completion: July 20, 2025
• Study Completion: August 20, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share