Nasopharyngeal Carcinoma (NPC)NPCNCT07011329
Brain Alterations Based on Multiplex MR Imaging in Nasopharyngeal Carcinoma Patients After Treatment, and Their Correlation With Clinical Cognitive Scores.
An observational study of Nasopharyngeal Carcinoma (NPC), run by Hubei Cancer Hospital at 1 site in China.
Trial summary
The objective of this study is to examine the potential impact of the treatment before, during, and/or after radiotherapy on the brain in patients with nasopharyngeal carcinoma (NPC) using Multiplex (MTP) MR imaging sequence, which generate multiple contrasts with one-time scan. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Changes in the brain MTP parameters after radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2027
- How long will I take part?
- 3 Years
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients
Who may be able to join
- pathological evidence of NPC (stages III-IV at diagnosis according to the 8th edition of the UICC/AJCC staging system for NPC)
- right-handed
- prepared to receive treatments
- prepared to receive the Montreal Cognitive Assessment (MoCA)
Who cannot join
- brain invasion
- brain tumor or atrophy, neural-associated diseases, a history of brain surgery
- any current medications that may affect cognitive function
- inability to attend MRI scanning
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430079
About this study
Official title: Brain Alterations Detected by Multiplex MR Imaging in Nasopharyngeal Carcinoma Patients After Treatment
The objective of this study is to examine the potential impact of the treatment before, during, and/or after radiotherapy on the brain in patients with nasopharyngeal carcinoma (NPC) using Multiplex (MTP) MR imaging sequence, which generate multiple contrasts with one-time scan. We aimed to investigate the altered MTP parameters and their correlation with clinical cognitive scores before and after the treatment.
Read the detailed description
Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in the head and neck region. Radiotherapy is the primary treatment for NPC patients, particularly those with T3 and T4 stages. However, radiotherapy often induces brain changes during the acute phase, early delayed phase, or late delayed phase, which may even lead to temporal lobe brain injury and subsequent cognitive impairment. Conventional magnetic resonance imaging (MRI) typically fails to detect corresponding radiological alterations in the brain regions affected by these delayed reactions, even when cognitive dysfunction manifests in patients as early as 6 months post-radiotherapy, so as the other treatment. Previous structural MRI studies (e.g., diffusion tensor imaging [DTI], voxel-based morphometry [VBM]) and resting-state functional MRI analyses (e.g., regional homogeneity [ReHo], functional connectivity [FC], graph theory-based methods) have demonstrated that subtle structural changes and functional abnormalities can be observed prior to apparent radiological changes in NPC patients post-radiotherapy. Additionally, radiomics models based on machine learning have shown promise in predicting early radiation-induced brain injury. However, conventional MRI sequences provide limited imaging information, involve cumbersome and complex data processing, and cannot simultaneously integrate multiple imaging modalities or analyze diverse parameters in a single scan. Therefore, developing a novel MRI imaging technique capable of rapidly, simply, and efficiently detecting induction/radiation-induced brain injury or necrosis in NPC patients during the early stages remains a critical challenge for improving survival outcomes and prognosis in clinical practice.
Multiparametric quantitative magnetic resonance imaging (MulTipLex, MTP) is an emerging technique that enables simultaneous acquisition of multiple contrast mechanisms and quantitative physicochemical parameters in a single scan. This technology has been widely applied in the diagnosis and quantitative analysis of neurological disorders such as Alzheimer's disease, Parkinson's disease, temporal lobe epilepsy, and tuberous sclerosis. It has also been utilized for prognostic prediction of cerebral infarction and integrated with multimodal imaging (e.g., PET-MRI, nuclear medicine) to assist in the staging of nasopharyngeal carcinoma, prostate cancer, and cervical cancer. Notably, MTP offers rapid imaging acquisition, mature technical workflows for brain segmentation and quantitative analysis, and comprehensive data fusion capabilities. To date, no studies have investigated the application of MTP in evaluating induction/radiation-induced cognitive dysfunction following NPC before, during, and/or after radiotherapy.
All patients underwent MTP imaging and Montreal Cognitive Assessment (MoCA) tests between different treatment courses.All MRI data were acquired using a 3.0 T MRI scanner (uMRI 790; United Imaging Healthcare, Shanghai, China) equipped with a 32-channel phased-array head coil. A single MTP scan allowing for the acquisition of multiple contrasts, including aT1W, SWI, cPDW, cT1w, T2Star, T1Map, PDMap, R2Star, and quantitative susceptibility mapping (QSM), was collected for each subjec.The MTP data were analyzed using BrainTool software. Then a single-group paired t-test, Pearson's correlations,a two-sample t-test, Receiver operating characteristic curve (ROC) analyses were utilized to analyse those MTP data and clinical data.
We hypothesis the MTP MR sequence can effectively evaluate brain alterations and cognitive impairment in NPC patients following their teratment.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Changes in the brain MTP parameters after radiotherapy
- Keywords
- npc, MTP, Cognitive decline
- Medical subject headings
- Nasopharyngeal Carcinoma, Niemann-Pick Disease, Type A, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in the brain MTP parameters after radiotherapyRadiation
Our study explores the changes in brain MTP parameters and their correlation with clinical cognitive scores before and after chemotherapy and/or radiotherapy in patients with NPC. We investigates MRI-derived multiparametric imaging biomarkers (MTP) as predictive biomarkers for chemotherapy/radiotherapy-induced cognitive decline in nasopharyngeal carcinoma, aiming to optimize neurotoxicity risk stratification and guide personalized neuroprotective interventions in precision oncology.
| Study group | Role | What they receive |
|---|---|---|
| before(pre-) and after (post-) treatment groups | The pre-treatment group refers to before treatment, while the post-treatment group refers to after treatment. Receives: Radiation: Changes in the brain MTP parameters after radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume
the brain volume changes after treatment in NPC patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies 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
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liu, Hubei Cancer Hospital
- Investigators
- Zilong Yuan, MD, Study director, Hubei Cancer HospitalDan Liu, MD, Study chair, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011329
- Sponsor's protocol ID
- LLHBCH2023YN-019
- Acronym
- NPC
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw/processed data required to reproduce these findings cannot be shared at this time as the data also forms part of an ongoing study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Alterations Detected by Multiplex MR Imaging in Nasopharyngeal Carcinoma Patients After Treatment
- ClinicalTrials.gov ID
- NCT07011329
- Acronym / sponsor ID
- NPC / LLHBCH2023YN-019
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- npc, MTP, Cognitive decline
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 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.
The objective of this study is to examine the potential impact of the treatment before, during, and/or after radiotherapy on the brain in patients with nasopharyngeal carcinoma (NPC) using Multiplex (MTP) MR imaging sequence, which generate multiple contrasts with one-time scan. We aimed to investigate the altered MTP parameters and their correlation with clinical cognitive scores before and after the treatment.
Detailed description
Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in the head and neck region. Radiotherapy is the primary treatment for NPC patients, particularly those with T3 and T4 stages. However, radiotherapy often induces brain changes during the acute phase, early delayed phase, or late delayed phase, which may even lead to temporal lobe brain injury and subsequent cognitive impairment. Conventional magnetic resonance imaging (MRI) typically fails to detect corresponding radiological alterations in the brain regions affected by these delayed reactions, even when cognitive dysfunction manifests in patients as early as 6 months post-radiotherapy, so as the other treatment. Previous structural MRI studies (e.g., diffusion tensor imaging [DTI], voxel-based morphometry [VBM]) and resting-state functional MRI analyses (e.g., regional homogeneity [ReHo], functional connectivity [FC], graph theory-based methods) have demonstrated that subtle structural changes and functional abnormalities can be observed prior to apparent radiological changes in NPC patients post-radiotherapy. Additionally, radiomics models based on machine learning have shown promise in predicting early radiation-induced brain injury. However, conventional MRI sequences provide limited imaging information, involve cumbersome and complex data processing, and cannot simultaneously integrate multiple imaging modalities or analyze diverse parameters in a single scan. Therefore, developing a novel MRI imaging technique capable of rapidly, simply, and efficiently detecting induction/radiation-induced brain injury or necrosis in NPC patients during the early stages remains a critical challenge for improving survival outcomes and prognosis in clinical practice.
Multiparametric quantitative magnetic resonance imaging (MulTipLex, MTP) is an emerging technique that enables simultaneous acquisition of multiple contrast mechanisms and quantitative physicochemical parameters in a single scan. This technology has been widely applied in the diagnosis and quantitative analysis of neurological disorders such as Alzheimer's disease, Parkinson's disease, temporal lobe epilepsy, and tuberous sclerosis. It has also been utilized for prognostic prediction of cerebral infarction and integrated with multimodal imaging (e.g., PET-MRI, nuclear medicine) to assist in the staging of nasopharyngeal carcinoma, prostate cancer, and cervical cancer. Notably, MTP offers rapid imaging acquisition, mature technical workflows for brain segmentation and quantitative analysis, and comprehensive data fusion capabilities. To date, no studies have investigated the application of MTP in evaluating induction/radiation-induced cognitive dysfunction following NPC before, during, and/or after radiotherapy.
All patients underwent MTP imaging and Montreal Cognitive Assessment (MoCA) tests between different treatment courses.All MRI data were acquired using a 3.0 T MRI scanner (uMRI 790; United Imaging Healthcare, Shanghai, China) equipped with a 32-channel phased-array head coil. A single MTP scan allowing for the acquisition of multiple contrasts, including aT1W, SWI, cPDW, cT1w, T2Star, T1Map, PDMap, R2Star, and quantitative susceptibility mapping (QSM), was collected for each subjec.The MTP data were analyzed using BrainTool software. Then a single-group paired t-test, Pearson's correlations,a two-sample t-test, Receiver operating characteristic curve (ROC) analyses were utilized to analyse those MTP data and clinical data.
We hypothesis the MTP MR sequence can effectively evaluate brain alterations and cognitive impairment in NPC patients following their teratment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before(pre-) and after (post-) treatment groups | – | Radiation: Changes in the brain MTP parameters after radiotherapyThe pre-treatment group refers to before treatment, while the post-treatment group refers to after treatment. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients
Key inclusion criteria (4 listed)
- pathological evidence of NPC (stages III-IV at diagnosis according to the 8th edition of the UICC/AJCC staging system for NPC)
- right-handed
- prepared to receive treatments
- prepared to receive the Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (4 listed)
- brain invasion
- brain tumor or atrophy, neural-associated diseases, a history of brain surgery
- any current medications that may affect cognitive function
- inability to attend MRI scanning
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 |
|---|---|---|
| Changes in the brain MTP parameters after radiotherapyOur study explores the changes in brain MTP parameters and their correlation with clinical cognitive scores before and after chemotherapy and/or radiotherapy in patients with NPC. We investigates MRI-derived multiparametric imaging biomarkers (MTP) as predictive biomarkers for chemotherapy/radiotherapy-induced cognitive decline in nasopharyngeal carcinoma, aiming to optimize neurotoxicity risk stratification and guide personalized neuroprotective interventions in precision oncology. | Radiation | before(pre-) and after (post-) treatment groups |
Primary outcome
volume
Time frame: 3 months
the brain volume changes after treatment in NPC patients
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 11 Jun 2025.
- United Imaging Healthcare Official Website of uAiFI Techology including brain analysis based on MTPLink provided by the sponsor.
- United Imaging Healthcare Official Chinese Website of uAiFI Techology including brain analysis, which used brainTool software based on MTPLink provided by the sponsor.
- Individual participant dataSharing planned: No. The raw/processed data required to reproduce these findings cannot be shared at this time as the data also forms part of an ongoing study.
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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. This study is not recruiting at the moment.
Zilong Yuan, MD study director
Hubei Cancer Hospital
Dan Liu, MD study chair
Hubei Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma (NPC), run by Hubei Cancer Hospital at 1 site in China.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume (time frame: 3 months). 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 11 Jun 2025.