NCT02411864

Brief Summary

Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

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 Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

1 month

First QC Date

December 10, 2014

Last Update Submit

July 2, 2017

Conditions

Healthy Volunteers

Keywords

IVIMbraindiffusion-weighted imaging

Outcome Measures

Primary Outcomes (1)

  • Parameters D* and f in healthy white matter or gray mater

    2-3 days

Study Arms (5)

Group 1

Low b=(0,50,150,200)，NEX=(1,3,2,2)

Other: different low b-values distribution

Group 2

Low b=(0,30,50,100,200)，NEX=(1,3,3,2,2)

Other: different low b-values distribution

Group 3

Low b=(0,30,60,90,120,150,180,200)，NEX=(1,3,3,3,2,2,2,2)

Other: different low b-values distribution

Group 4

Low b=(0,30,60,90,120,150,180,200)，NEX=(1,1,1,1,1,1,1,1)

Group 5

Low b=(0,20,40,60,80,100,120,140,160,180,200)NEX=(1,3,3,3,3,2,2

Other: different low b-values distribution

Interventions

different low b-values distributionOTHER
Group 1Group 2Group 3Group 5

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy volunteers

You may qualify if:

  • no hypertension or cerebral vascular diseases,
  • no systemic metabolic disease;
  • no infection or fever;
  • no use of corticosteroid drugs;
  • no MRI contraindication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

December 10, 2014

First Posted

April 8, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 5, 2017

Record last verified: 2017-07