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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer
• Intervention / Treatment: Other: IVIM Imaging MRF Imaging

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: 蔚 吴; Phone Number: 15689030575; Email: ww1538067425@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Head and Neck Cancer

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-parametric MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hainan People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): July 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia
• Other Study ID Numbers: WuWei-2025-NPC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No