NCT00001619

Brief Summary

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a substance called gadolinium. Gadolinium works by brightening areas of the magnetic resonance image, thereby improving the contrast. In this study researchers will use magnetic resonance imaging and contrast substances, like gadolinium, on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 5, 1996

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
11.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2011

Completed
Last Updated

July 2, 2017

Status Verified

July 20, 2011

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

ImagingSpectroscopyMRICardiovascularTechnical DevelopmentHeartSafetyToxicityGadoliniumAdverse EventsNormal Volunteer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any normal volunteer greater than or equal to 18 who is capable of giving informed consent.

You may not qualify if:

  • A subject will be excluded if he/she has a contraindication to MR scanning such as:
  • Brain aneurysm clip
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or defibrillator
  • Cochlear or ear implant
  • Ocular foreign body (e.g. metal shavings)
  • Insulin pump
  • Pregnant women (when uncertain, subject will undergo urine or blood testing).
  • Claustrophobia
  • Any condition in the Principal Investigator's judgement which present unnecessary risk
  • Lactating Women
  • Renal or hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.

    PMID: 7862963BACKGROUND
  • Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.

    PMID: 1889423BACKGROUND
  • Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.

    PMID: 7928216BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

November 5, 1996

Study Completion

July 20, 2011

Last Updated

July 2, 2017

Record last verified: 2011-07-20

Locations