NCT00611013

Brief Summary

Evaluating novel MR imaging techniques on volunteers.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

10.1 years

First QC Date

January 12, 2008

Last Update Submit

June 19, 2013

Conditions

Keywords

Development of multi-purpose novel imaging protocols

Outcome Measures

Primary Outcomes (1)

  • General purpose novel magnetic resonance imaging contrasts, developments for improved magnetic resonance image quality

    10 years

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy normal volunteers for imaging protocol optimization.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Functional Onco-Imaging, University of California

Irvine, California, 92697, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Lutfi T Muftuler, Ph.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2008

First Posted

February 8, 2008

Study Start

June 1, 2002

Primary Completion

July 1, 2012

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations