Magnetic Resonance Imaging and Spectroscopy at High Field - Full Text View

Purpose

Evaluating novel MR imaging techniques on volunteers.

Condition	Intervention
Healthy	Device: Magnetic Resonance Imaging

MedlinePlus related topics:

MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment

Official Title:	Magnetic Resonance Imaging and Spectroscopy at High Field

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

General purpose novel magnetic resonance imaging contrasts, developments for improved magnetic resonance image quality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	June 2002
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Some participants may receive MRI contrast agent, 0.1 mmol/kg

Detailed Description:

The aim of this study is twofold. The first aim is to evaluate new MRI techniques developed by the investigators of this protocol on human volunteers. The second aim is to assist other investigators who need to use MR images obtained on this device for their own research. MR images and/or spectroscopy data will be acquired from the participants in this protocol.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy normal volunteers for imaging protocol optimization.

Exclusion Criteria:

Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported),
Patients with compromised thermoregulatory systems (e.g. certain cancer patients),
Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
Patients with implanted prosthetic heart valves,
Patients with pacemakers, neuro-stimulation devices,
Pregnant patients (the safety of magnetic resonance examination has not been completely established for embryos and fetuses),
Subjects who have received orthodontic work involving ferromagnetic materials,
Subjects who have claustrophobia, and
The patients unwilling to participate in the study or fail to sign the consent form.
Subjects who are pregnant or breast-feeding will be excluded from the contrast enhanced MRI studies.
Subjects who had allergic response to contrast agents previously will be excluded from contrast enhanced MRI studies.
Subjects with known history of asthma, allergic conditions, severe renal insufficiency, sickle cell anemia, chronic hemolytic anemia, gastrointestinal disorders will also be excluded from contrast enhanced MRI studies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611013

Contacts


Contact: Lutfi T Muftuler, Ph.D.	949-824-6001	tugan.muftuler@uci.edu

Locations


United States, California
	Center for Functional Onco-Imaging, University of California	Recruiting
	Irvine, California, United States, 92697
	Contact: Diane Huebner 949-824-6001 dkhuebne@uci.edu
	Principal Investigator: Lutfi T Muftuler, Ph.D

Sponsors and Collaborators

University of California, Irvine

Investigators


Principal Investigator:	Lutfi T Muftuler, Ph.D.	University of California, Irvine

More Information

Responsible Party:	University of California, Irvine ( L. Tugan Muftuler )
Study ID Numbers:	UCI-HS-2002-2611
First Received:	January 12, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00611013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Development of multi-purpose novel imaging protocols

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00611013