Nasopharyngeal Carcinoma ,Xerostomia,RadiotherapyNCT06751381
Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
An observational study of Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy, run by Hainan Medical College.
Trial summary
This prospective observational study aims to evaluate the role of intravoxel incoherent motion (IVIM) imaging and magnetic resonance fingerprinting (MRF) techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
- What is being tested?
- IVIM Imaging MRF Imaging
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 6 Dec 2026
- 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 (aged 18 years or older) with a confirmed diagnosis of nasopharyngeal carcinoma who are scheduled to undergo radiotherapy as part of standard treatment. Recruitment will occur at the Department of Radiotherapy, Hainan Provincial People's Hospital. Eligibility requires the ability to undergo MRI scans and the provision of 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: A Prospective Study on Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
This prospective observational study aims to evaluate the role of intravoxel incoherent motion (IVIM) imaging and magnetic resonance fingerprinting (MRF) techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients undergoing radiotherapy. The study will recruit patients diagnosed with NPC who are receiving standard radiotherapy, and quantitative imaging data will be collected using IVIM and MRF techniques at multiple time points, including pre-treatment, during radiotherapy, and post-treatment. The primary objective is to analyze changes in salivary gland structure and function and to identify early imaging biomarkers indicative of radiation-induced injury. The findings are expected to provide new insights into the dynamic progression of salivary gland damage, establish predictive models for the risk of xerostomia, and guide the development of personalized therapeutic strategies to mitigate long-term complications.
Read the detailed description
This is a prospective study designed to investigate the application of intravoxel incoherent motion (IVIM) and magnetic resonance fingerprinting (MRF) imaging techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients after radiotherapy. The study aims to quantify and assess salivary gland function changes during and after radiotherapy using advanced imaging technologies, with the goal of identifying early imaging biomarkers associated with radiation-induced damage.
Patients diagnosed with NPC and receiving standard radiotherapy will be recruited. Imaging data will be acquired at three time points: prior to radiotherapy (baseline), during radiotherapy (mid-course), and after radiotherapy (post-treatment). IVIM and MRF sequences will be performed to collect data on salivary gland microstructure, perfusion, and relaxation properties. These parameters will be analyzed to detect early changes in salivary gland function and correlate them with the development of xerostomia.
This study is expected to provide valuable insights into the utility of IVIM and MRF imaging in predicting and monitoring radiation-induced salivary gland damage. The findings may facilitate early intervention strategies and contribute to personalized radiotherapy planning aimed at minimizing xerostomia risk in NPC patients.
- Being tested
- IVIM Imaging MRF Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIM Imaging MRF ImagingDevice
IVIM imaging will be performed to evaluate microstructural and perfusion changes in the salivary glands of nasopharyngeal carcinoma patients 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 |
|---|---|---|
| Nasopharyngeal Carcinoma Patients | Not described Receives: Device: IVIM Imaging MRF Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure • Title: Quantitative assessment of salivary gland changes using IVIM and MRF imaging • Time Frame: From baseline to 6 months post-radiotherapy • Description: Quantification of salivary gland microstructural, perfusion, and re
IVIM Imaging: Quantification of salivary gland microstructural and perfusion changes using IVIM-derived parameters (D, D*, f values) to evaluate radiotherapy-induced changes.
MRF Imaging: Quantification of salivary gland relaxation properties using MRF-derived relaxation times (T1 and T2 mapping) to evaluate radiotherapy-induced changes.
Unit of Measure:
IVIM: D, D*, f values MRF: T1 and T2 relaxation times Analysis: Changes in salivary gland microstructure and perfusion (IVIM parameters) as well as relaxation properties (MRF parameters) will be assessed separately from baseline to 6 months post-radiotherapy.
Measured: From baseline to 6 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 posted27 Dec 2024
- Study start20 Jan 2025 (estimated)
- Primary completion6 Jun 2026 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma ,Xerostomia,RadiotherapyStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hainan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shui Bin Juan, Hainan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751381
- Sponsor's protocol ID
- ShuiBinJuan-2024-NPC001
- Status last verified
- Jan 2025
- First submitted
- 12 Dec 2024
- Last updated
- 14 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Monitoring Salivary Gland Injury in Nasopharyngeal Carcinoma Patients After Radiotherapy Using Multi-Modal Radiomics
- ClinicalTrials.gov ID
- NCT06751381
- Acronym / sponsor ID
- ShuiBinJuan-2024-NPC001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hainan Medical CollegeUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
This prospective observational study aims to evaluate the role of intravoxel incoherent motion (IVIM) imaging and magnetic resonance fingerprinting (MRF) techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients undergoing radiotherapy. The study will recruit patients diagnosed with NPC who are receiving standard radiotherapy, and quantitative imaging data will be collected using IVIM and MRF techniques at multiple time points, including pre-treatment, during radiotherapy, and post-treatment. The primary objective is to analyze changes in salivary gland structure and function and to identify early imaging biomarkers indicative of radiation-induced injury. The findings are expected to provide new insights into the dynamic progression of salivary gland damage, establish predictive models for the risk of xerostomia, and guide the development of personalized therapeutic strategies to mitigate long-term complications.
Detailed description
This is a prospective study designed to investigate the application of intravoxel incoherent motion (IVIM) and magnetic resonance fingerprinting (MRF) imaging techniques in monitoring salivary gland injury in nasopharyngeal carcinoma (NPC) patients after radiotherapy. The study aims to quantify and assess salivary gland function changes during and after radiotherapy using advanced imaging technologies, with the goal of identifying early imaging biomarkers associated with radiation-induced damage.
Patients diagnosed with NPC and receiving standard radiotherapy will be recruited. Imaging data will be acquired at three time points: prior to radiotherapy (baseline), during radiotherapy (mid-course), and after radiotherapy (post-treatment). IVIM and MRF sequences will be performed to collect data on salivary gland microstructure, perfusion, and relaxation properties. These parameters will be analyzed to detect early changes in salivary gland function and correlate them with the development of xerostomia.
This study is expected to provide valuable insights into the utility of IVIM and MRF imaging in predicting and monitoring radiation-induced salivary gland damage. The findings may facilitate early intervention strategies and contribute to personalized radiotherapy planning aimed at minimizing xerostomia risk in NPC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal Carcinoma Patients | – | Device: 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 (aged 18 years or older) with a confirmed diagnosis of nasopharyngeal carcinoma who are scheduled to undergo radiotherapy as part of standard treatment. Recruitment will occur at the Department of Radiotherapy, Hainan Provincial People's Hospital. Eligibility requires the ability to undergo MRI scans and the provision of 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 nasopharyngeal carcinoma patients 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. | Device | Nasopharyngeal Carcinoma Patients |
Primary outcome
Primary Outcome Measure • Title: Quantitative assessment of salivary gland changes using IVIM and MRF imaging • Time Frame: From baseline to 6 months post-radiotherapy • Description: Quantification of salivary gland microstructural, perfusion, and re
Time frame: From baseline to 6 months post-radiotherapy
IVIM Imaging: Quantification of salivary gland microstructural and perfusion changes using IVIM-derived parameters (D, D*, f values) to evaluate radiotherapy-induced changes. MRF Imaging: Quantification of salivary gland relaxation properties using MRF-derived relaxation times (T1 and T2 mapping) to evaluate radiotherapy-induced changes. Unit of Measure: IVIM: D, D*, f values MRF: T1 and T2 relaxation times Analysis: Changes in salivary gland microstructure and perfusion (IVIM parameters) as well as relaxation properties (MRF parameters) will be assessed separately from baseline to 6 months post-radiotherapy.
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 14 Jan 2025.
- Individual participant dataSharing planned: No
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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 Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy, run by Hainan Medical College.
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 14 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 Binjuan Shui (+15256895038, 3131683430@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure • Title: Quantitative assessment of salivary gland changes using IVIM and MRF imaging • Time Frame: From baseline to 6 months post-radiotherapy • Description: Quantification of salivary gland microstructural, perfusion, and re (time frame: From baseline to 6 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 14 Jan 2025.