Abdominal MR Imaging at 3.0T: Sequence Optimization and I... | NCT01007357

Studies
Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation

NCT01007357

Sponsor

University of Nebraska

Status

Terminated

Last Update Posted

Jul 14, 2023Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Diffuse and Focal Abnormalities of the Liver and Pancreas

Interventions

Body MR imaging

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator left institution; did not complete the study

Expanded Access Info

Start Date

Dec 15, 2009Actual

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Nov 3, 2009

First Posted Date

Nov 4, 2009Estimated

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

Jul 12, 2023

Last Update Posted Date

Jul 14, 2023Actual

Name	Class
Philips Medical Systems	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

This project will facilitate the optimization of body MR imaging at 3 Tesla.

Detailed Description

This project is meant to improve the image quality of multiple sequences at 3.0T applied to the abdominal and pelvic regions.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Body MRI healthy volunteers	Other	Body MRI to optimize sequences in healthy individuals and in disorder subjects	Device: Body MR imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Body MR imaging	Device	Body MR imaging will be performed to optimize sequences	Body MRI healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optimizing body MR imaging sequences	Healthy volunteers will be used to obtain optimized body MR imaging sequences that will then be used to evaluate MR imaging sequences of subjects with underlying disorders.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects between ages of 19 and 65
Healthy volunteer subjects should not have any history of disease or symptoms - based on clinical history
Subjects with an underlying disorder (diffuse and focal abnormalities of the liver and pancreas)

Exclusion Criteria:

Inability to provide informed consent
A medical or contraindications that will prevent subjects from having a MRI
Subjects with severe renal dysfunction or patients on dialysis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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	68198-1045	United States
University of Nebraska Medical Center

Type	Date	Date Unknown
Release	Jul 15, 2023
Reset	Jul 31, 2023
Release	Nov 29, 2023
Reset	Dec 20, 2023
Release	Dec 20, 2023
Reset	Jan 16, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 15, 2023			Jul 31, 2023
Nov 29, 2023