Syngo NATIVE Contrast Enhanced 3D MRA on 3T Verio Magnet | NCT02065648

Studies
Syngo NATIVE Contrast Enhanced 3D MRA on 3T Verio Magnet

NCT02065648

Sponsor

Cedars-Sinai Medical Center

Status

Completed

Last Update Posted

Feb 12, 2025Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Vascular Disease

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

Feb 2025

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 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jan 17, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 19, 2014Estimated

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 10, 2025

Last Update Posted Date

Feb 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rola Saouaf, MD, Director, Body and Cardiac MRI, Cedars-Sinai Medical CenterPrincipal Investigator

Lead Sponsor

Cedars-Sinai Medical CenterOTHER

Collaborators

Name	Class
Siemens Corporation, Corporate Technology	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo NATIVE sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA performed as part of routine clinical care in patients with normal renal function to determine if the non-contrast NATIVE sequence is a viable alternative to contrast enhanced MRA in patients with renal insufficiency. There are no interventions--this is an observational study.

Detailed Description

If the NATIVE sequence proves to be a viable alternative to contrast enhanced MRA it will provide imaging physicians with the diagnostic tool to assess vascular disease in patients with renal insufficiency without placing them at risk for additional co-morbidities.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Syngo NATIVE MRA		All consenting participants will receive an additional non-contrast Syngo NATIVE MRA sequence prior to contrast injection their standard of care MRA.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of non-contrast enhanced MRA sequence	Compare non-contrast enhanced MRA images with contrast-enhanced MRA images.	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over age 18 Signed informed consent Referred for standard of care MRA

Exclusion Criteria:

No contra-indications for MRI/MRA ie implants which could interfere with magnets Renal insufficiency which would preclude use of contrast-enhanced contrast for a standard of care MRA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Consenting patients referred for standard of care contrast-enhanced abdominal MR Angiography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rola Saouaf, MD	Cedars-Sinai Medical Center	Principal Investigator
Franklin G. Moser, MD	Cedars-Sinai Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	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

Condition Browse Module

MeSH Terms

ID	Term
D014652	Vascular Diseases

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided