Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck CancerNCT06792526
Prospective Study on Monitoring Parotid Gland Injury After Radiotherapy for Head and Neck Tumors Using Multimodal Radiomics
An observational study of Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer, run by Hainan People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer
- What is being tested?
- IVIM Imaging MRF Imaging
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 20 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- IVIM Imaging MRF Imaging
- Medical subject headings
- Xerostomia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIM Imaging MRF ImagingOther
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 group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer | Not described Receives: Other: IVIM Imaging MRF Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 3 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hainan People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Wei, Hainan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792526
- Sponsor's protocol ID
- WuWei-2025-NPC002
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Salivary Gland Damage After Radiotherapy in Patients with Head and Neck Cancer Using Multimodal Radiomics
- ClinicalTrials.gov ID
- NCT06792526
- Acronym / sponsor ID
- WuWei-2025-NPC002
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hainan People's HospitalUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer | – | Other: IVIM Imaging MRF Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIM Imaging MRF ImagingIVIM 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. | Other | Head and Neck Cancer |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia, Radiation-induced Parotid Damage,Predictivevalue,Head and Neck Cancer, run by Hainan People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 蔚 吴 (15689030575, ww1538067425@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative assessment of salivary gland changes using IVIM and MRF imaging (time frame: From baseline to 3 months post-radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.