Refinement and Assessment of New Magnetic Resonance Imagi... | NCT00738712

Studies
Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies for Vascular, Abdominal, and Pelvic Exams

NCT00738712

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Jan 13, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

MRI Magnetic Resonance 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

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

Jan 2021

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

May 2, 2011Actual

Primary Completion Date

Jan 14, 2020Actual

Completion Date

Jan 14, 2020Actual

First Submitted Date

Aug 19, 2008

First Submission Date that Met QC Criteria

Aug 19, 2008

First Posted Date

Aug 20, 2008Estimated

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

Jan 11, 2021

Last Update Posted Date

Jan 13, 2021Actual

Name	Class
General Electric	INDUSTRY
Philips Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 study is being done to assess new Magnetic Resonance Imaging (MRI) technologies designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions.

Detailed Description

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions. Software and hardware are always being improved, new machines replace old machines, software is updated and improved as well as devices used to produce better MRI images.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
New MRI techniques	Experimental	New hardware or software technologies designed to improve MRI (Magnetic Resonance Imaging) exams.	Procedure: MRI Magnetic Resonance Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI Magnetic Resonance Imaging	Procedure	MRI	New MRI techniques	Magnetic Resonance Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of new software in MRI vascular imaging	New software technology will be utilized to enhance MRI imaging of the vascular regions of the body.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or non-pregnant female patient
18 years or older
any ethnic background
presenting to MRI for a clinically-ordered chest MRI exam.

Exclusion Criteria:

Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
Pregnant patients or patients who are lactating.
A patient who is claustrophobic

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Masch, MD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Health Center		Ann Arbor	Michigan	48109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided