NCT03570086

Brief Summary

Recently, radiomics combined with machine learning method has been widely used in clinical practice. Compared with traditional imaging studies that explore the underlying mechanisms, the machine learning method focuses on classification and prediction to propose personalized diagnosis and treatment strategies. However, these studies were based on thin-section research-quality brain MR imaging with section thickness of \< 2 mm. Clinical, the usage of thick-section clinical setting instead of thin-section research setting is especially important to shorten the acquisition time to reduce the patient's suffering. Here investigators want to build multiparametric diagnostic model of migraineurs without aura using radiomics features extracted from thick-section clinical-quality brain MR images.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

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

May 28, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

May 28, 2018

Last Update Submit

June 24, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • accuracy

    a measure of statistical bias which measures the proportion of health controls and migrainures that are correctly identified as such.

    2018.7-2019.12

  • sensitivity

    true positive rate of detection in migraineurs which measures the proportion of actual migraineurs that are correctly identified as such.

    2018.7-2019.12

  • specificity

    true negative rate measures the proportion of actual health controls that are correctly identified as such.

    2018.7-2019.12

Study Arms (2)

migraineurs without aura

Diagnostic Test: diagnostic

health controls

Diagnostic Test: diagnostic

Interventions

diagnosticDIAGNOSTIC_TEST

using radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls.

health controlsmigraineurs without aura

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

200 migraineurs without aura 200 age- and gender-matched health controls (HCs)

You may qualify if:

  • right-handed
  • International Headache Society criteria for episodic migraine without aura

You may not qualify if:

  • addition (including alcohol, nicotine, or drug)
  • physical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Migraine without Aura

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 26, 2018

Study Start

July 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2019

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations