General Investigative MRI Protocol | NCT01598766

Studies
General Investigative MRI Protocol

NCT01598766

Sponsor

Toshiba America Medical Systems, Inc.

Status

Unknown status

Last Update Posted

Feb 5, 2013Estimated

Enrollment

100Estimated

Phase

Phase 1

Conditions

Multiple MRI Exams, Including
Cardiac
Abdominal
Lumbar
Neck
Pelvis

Interventions

16 Channel SPEEDER Flex Coil

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

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

May 2013Estimated

Completion Date

May 2020Estimated

First Submitted Date

May 11, 2012

First Submission Date that Met QC Criteria

May 11, 2012

First Posted Date

May 15, 2012Estimated

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

Feb 4, 2013

Last Update Posted Date

Feb 5, 2013Estimated

Description Module

Brief Summary

This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.

Detailed Description

Not provided

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic Coil	Experimental	This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams	Device: 16 Channel SPEEDER Flex Coil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
16 Channel SPEEDER Flex Coil	Device	This is a 16 element MRI coil, flexible, lightweight. Multiple uses.	Diagnostic Coil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
16 Channel Flex Coil	The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.	May 2012-May 2013

Secondary Outcomes

Measure	Description	Time Frame
8 Channel Value Breast Coil	clinical evaluation to determine if an 8 channel mri breast coil meets industry standards.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.

Exclusion Criteria:

Any contraindication to MRI procedures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erin Kelly	Contact	7146046242		ekelly@tams.com

Overall Officials

Name	Affiliation	Role
Mark L Winkler, MD	Steinberg Diagnostic Medical Imaging	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Steinberg Diagnostic Medical Imaging	Recruiting	Henderson	Nevada	89052	United States