NCT03775694

Brief Summary

The purpose of the dMRI-1 data collection study is to establish a database of clinical images and limited medical history information from patients that have previously received a dMRI scan. All data collected will be de-identified. No safety or effectiveness assessments will be completed.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

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

First Submitted

Initial submission to the registry

December 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

December 12, 2018

Last Update Submit

May 3, 2022

Conditions

EpilepsyTumorHealthyOther

Outcome Measures

Primary Outcomes (1)

  • Image assessment

    Procedure

Interventions

dMRI ScanDEVICE

Data will be collected from cases where dMRI scans were obtained as part of the subject's previous treatment.

Eligibility Criteria

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

Patients who have previously received a dMRI scan.

You may qualify if:

  • Patient is either ≥ 18 years and has previously received an acceptable dMRI scan(s) with at least 30 unique gradient directions or \< 18 years who has previously received an acceptable dMRI scan of any number of unique gradient directions and who is allowed to participate in this type of research project (e.g., IRB/EC approval with waiver of consent) per IRB/EC
  • Acceptable dMRI scan was completed prior to site activation in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

University of Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

EpilepsyNeoplasms

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 14, 2018

Study Start

June 6, 2019

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

US(3)CA(3)