NCT05287750

Brief Summary

This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting brain diseases. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress94%
Jan 2022Sep 2026

Study Start

First participant enrolled

January 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

January 7, 2022

Last Update Submit

March 15, 2022

Conditions

Brain TumorMRICerebrovascular Disease

Keywords

Brain tumorCerebrovascular diseaseMRIUltra high field

Outcome Measures

Primary Outcomes (2)

  • the correspondence between brain tumor cells found in the biopsies and region of interest(ROI) signal intension on the 7T MRI scan and 3T MRI scan

    Pathological assessment of biopsy material compared with the lesion's contrast-enhancement signal intension to normal brain white mater on 7T MRI and 3T MRI

    within a month after biopsy

  • The visibility of white matter tracts on 7T MRI

    Visualization of white matter tracts will be done with the use of diffusion tensor imaging (DTI) on 7T MRI and measuring the mean diffusivity (MD) value on Post-processing workstation ,and analysis the correlation between these values and pathological.

    within a month after biopsy

Secondary Outcomes (2)

  • The correlation between the ROI's signal intension on 7T MRI scan and the KPS in 1 month after operation

    within a month after biopsy

  • The visibility of white matter tracts on 7T MRI and 3T MRI

    Six months after the biopsy

Interventions

Magnetic resonance imagingDIAGNOSTIC_TEST

Patients recruited will receive Magnetic resonance imaging.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥18 and ≤80
  • Having brain diseases (eg: brain tumor, cerebrovascular diseases)
  • Having no contraindications against MRI or intravenous contrast agent administration
  • Clinically stable

You may not qualify if:

  • Age\<18 or \>80
  • Pregnancy and other contraindication to MRI scan
  • Informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related Publications (2)

  • Duan Q, Lyu J, Liu Z, Hao F, Li R, Liu S, Hao X, Li J, Bian X, Duan C, Wang S, Wang W, Wang R, Duan L, Lou X. Noninvasive Assessment of the Risk Features of Hemorrhage in Moyamoya Disease Using 7T MRI. Neurology. 2025 Jun 10;104(11):e213617. doi: 10.1212/WNL.0000000000213617. Epub 2025 May 21.

    PMID: 40397837DERIVED

  • Duan C, Bian X, Cheng K, Lyu J, Xiong Y, Xiao S, Wang X, Duan Q, Li C, Huang J, Hu J, Wang ZJ, Zhou X, Lou X. Synthesized 7T MPRAGE From 3T MPRAGE Using Generative Adversarial Network and Validation in Clinical Brain Imaging: A Feasibility Study. J Magn Reson Imaging. 2024 May;59(5):1620-1629. doi: 10.1002/jmri.28944. Epub 2023 Aug 9.

    PMID: 37559435DERIVED

MeSH Terms

Conditions

Brain NeoplasmsCerebrovascular Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Kun Cheng, M.S.

CONTACT

+86 19921784434dr_chengkun@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Clinical Professor

Study Record Dates

First Submitted

January 7, 2022

First Posted

March 18, 2022

Study Start

January 1, 2022

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

CN(1)