Magnetic Resonance Imaging and Spectroscopy at High Field

Healthy Clinical Trial

Official title:

Magnetic Resonance Imaging and Spectroscopy at High Field

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00611013
• Other study ID #: UCI-HS-2002-2611
• Status: Withdrawn
• Phase: N/A
• First received: January 12, 2008
• Last updated: June 19, 2013
• Start date: June 2002

Study information

• Verified date: June 2013
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Evaluating novel MR imaging techniques on volunteers.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Magnetic Resonance Imaging
Some participants may receive MRI contrast agent, 0.1 mmol/kg

Locations

Country	Name	City	State
United States	Center for Functional Onco-Imaging, University of California	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General purpose novel magnetic resonance imaging contrasts, developments for improved magnetic resonance image quality		10 years	No