General Investigative MRI Protocol

Cardiac Clinical Trial

Official title:

General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01598766
• Other study ID #: 05069
• Status: Recruiting
• Phase: Phase 1
• First received: May 11, 2012
• Last updated: February 4, 2013
• Start date: May 2012
• Est. completion date: May 2020

Study information

• Verified date: February 2013
• Source: Toshiba America Medical Systems, Inc.
• Contact: Erin Kelly
• Phone: 7146046242
• Email: ekelly[@]tams.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal
• Cardiac
• Lumbar
• Multiple MRI Exams, Including
• Neck
• Pelvis

Intervention

Device:
• 16 Channel SPEEDER Flex Coil
This is a 16 element MRI coil, flexible, lightweight. Multiple uses.

Locations

Country	Name	City	State
United States	Steinberg Diagnostic Medical Imaging	Henderson	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Toshiba America Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	16 Channel Flex Coil	The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients.	May 2012-May 2013	No
Secondary	8 Channel Value Breast Coil	clinical evaluation to determine if an 8 channel mri breast coil meets industry standards.	6 months	No