Rapid 10-Minute Liver MRI Protocol in Patients With Suspe... | NCT01390194

Studies
Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma

NCT01390194

Sponsor

University of Nebraska

Status

Completed

Last Update Posted

Sep 6, 2023Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Underlying Liver Disease
Hepatitis
Fibrosis of Liver
Cirrhosis With Suspicion of Liver Cancer
Lesion on a Prior Ultrasound, CT or Outside MRI

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2011Actual

Primary Completion Date

Jun 1, 2015Actual

Completion Date

Jun 1, 2015Actual

First Submitted Date

Jul 6, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2023

Last Update Posted Date

Sep 6, 2023Actual

Name	Class
Philips Medical Systems	INDUSTRY
Bracco Diagnostics, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
image quality outcome	Two MRI exams will be evaluated by two radiologists based on a number of items.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with an underlying liver disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shahid Hussain, MD	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198	United States

Condition Browse Module

MeSH Terms

ID	Term
D006505	Hepatitis
D008103	Liver Cirrhosis
D008107	Liver Diseases
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided