NCT04955509

Brief Summary

To construct and validate a software to recognize scar for patients with chronic SCI based on multimodal MRI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Status
unknown

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

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 8, 2021

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

June 29, 2021

Last Update Submit

July 1, 2021

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

  • Performance of the fitted model

    positive predictive value (PPV)

    through study completion, an average of 2 year

  • Performance of the fitted model

    sensitivity (SE)

    through study completion, an average of 2 year

  • Performance of the fitted model

    Dice coefficient score (DSC)

    through study completion, an average of 2 year

Study Arms (2)

Training

random splitting based on random sequences generated by engineers to train and optimize a machine learning model

Other: MRI

Testing

random splitting based on random sequences generated by engineers to evaluate the performance of the model

Other: MRI

Interventions

MRIOTHER

conventional MRI and diffusion MRI

TestingTraining

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients came from the Peking University Third Hospital.

You may qualify if:

  • (Prospective part) compliance to MRI scan
  • (Prospective part) no MRI contraindication
  • (Retrospective part) available conventional MRI data
  • clinical diagnosis of SCI (the course of disease≥1 year)

You may not qualify if:

  • prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, motor neuron disease, or spinal cord tumor
  • images with motion artifact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Huishu Yuan

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengze Zhang

CONTACT

18600393607zmzforever@pku.edu.cn

Ouyang Hanqiang

CONTACT

ouyanghanqiang@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

July 8, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share