NCT03490656

Brief Summary

The goals of this study are to (1) develop and optimize MRI acquisition and post-processing techniques and (2) to generate preliminary and comparative data on sequences for potential clinical trials.

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
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 21, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

8.2 years

First QC Date

February 22, 2018

Last Update Submit

January 16, 2024

Conditions

MRI Imaging

Outcome Measures

Primary Outcomes (4)

  • Image quality

    assessed by blinded readers

    through study completion, an average of 1-3 years

  • Artifacts

    assessed by blinded readers

    through study completion, an average of 1-3 years

  • Lesion detectability

    assessed by blinded readers

    through study completion, an average of 1-3 years

  • Image noise

    assessed region of interest over target tissue and background

    through study completion, an average of 1-3 years

Study Arms (2)

Healthy volunteer population

EXPERIMENTAL
Diagnostic Test: MRI Scan - not in addition to standard of care

Patient population

EXPERIMENTAL
Diagnostic Test: MRI Scan - in addition to standard of care

Interventions

MRI Scan - in addition to standard of careDIAGNOSTIC_TEST

Up to 3 Tesla (T) MRI

Patient population
MRI Scan - not in addition to standard of careDIAGNOSTIC_TEST

Up to 3 Tesla (T) MRI

Healthy volunteer population

Eligibility Criteria

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

You may qualify if:

  • Male and female volunteers greater than or equal to 18 years of age
  • Patients receiving a standard of care 1.5 or 3T MRI at The Ohio State University
  • Healthy volunteers that feel comfortable receiving an investigational mRI

You may not qualify if:

  • Participants with a contraindication to MRI. Such contraindications include, but are not limited to: pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, tattoos, implanted electronic infusion pumps or any other condition that would interfere with the MRI, a stent somewhere, a history of allergic reaction to any metals
  • Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
  • Participants with vital signs outside of normal range
  • Prisoners
  • Subjects incapable of giving informed written consent
  • Participants who are pregnant, healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michael V Knopp, MD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 22, 2018

First Posted

April 6, 2018

Study Start

October 21, 2016

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

US(1)