NCT01390194

Brief Summary

The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

July 6, 2011

Last Update Submit

August 30, 2023

Conditions

Underlying Liver DiseaseHepatitisFibrosis of LiverCirrhosis With Suspicion of Liver CancerLesion on a Prior Ultrasound, CT or Outside MRI

Keywords

liver diseasehepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • image quality outcome

    Two MRI exams will be evaluated by two radiologists based on a number of items.

    2 years

Study Arms (1)

subjects with an underlying liver disease

(1)underlying liver disease; (2) have a lesion on a prior imaging study; (3) must be prior standard MR

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with an underlying liver disease

You may qualify if:

  • underlying liver disease
  • have a lesion on a prior imaging study
  • must have prior standard MR

You may not qualify if:

  • Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
  • patients with severe kidney dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

HepatitisLiver CirrhosisLiver DiseasesCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Shahid Hussain, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations

US(1)