NCT07011329

Brief 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. We aimed to investigate the altered MTP parameters and their correlation with clinical cognitive scores before and after the treatment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Dec 2027

Study Start

First participant enrolled

April 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

June 11, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

May 30, 2025

Last Update Submit

June 7, 2025

Conditions

Keywords

npcMTPCognitive decline

Outcome Measures

Primary Outcomes (1)

  • volume

    the brain volume changes after treatment in NPC patients

    3 months

Study Arms (1)

before(pre-) and after (post-) treatment groups

The pre-treatment group refers to before treatment, while the post-treatment group refers to after treatment.

Radiation: Changes in the brain MTP parameters after radiotherapy

Interventions

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.

before(pre-) and after (post-) treatment groups

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430079, China

Location

Related Links

MeSH Terms

Conditions

Nasopharyngeal CarcinomaNiemann-Pick Disease, Type ACognitive Dysfunction

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesNiemann-Pick DiseasesSphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHistiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism DisordersCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Zilong Yuan, MD

    Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR
  • Dan Liu, MD

    Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician-in-charge

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

April 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

June 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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.

Locations