NCT00001874

Brief Summary

Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create 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 contrast substance. The contrast substance works by brightening areas of the magnetic resonance image. In this study researchers plan to use magnetic resonance imaging with contrast substances and exercise 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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 1999

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

February 22, 1999

Completed
8 months 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
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2009

Completed
Last Updated

July 2, 2017

Status Verified

August 3, 2009

Enrollment Period

10.5 years

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

ImagingSpectroscopyMRICardiovascularTechnical DevelopmentSafetyGadoliniumHeartToxicityAdverse EventsNormal Volunteer

Eligibility Criteria

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

You may qualify if:

  • Any normal volunteer above the age 18 who is capable of giving informed consent will be included.

You may not qualify if:

  • A subject will be excluded if he/she has a contradiction to MR scanning.
  • Brain aneurysm clip
  • Implanted neural stimulator
  • Implanted cardiac pacemaker implanted defibrillator
  • Cochlear implant
  • Ocular foreign body (e.g. metal shavings)
  • Insulin pump
  • Pregnant women (when uncertain, subjects will undergo urine or blood testing).
  • Kidney
  • Paralyzed hemidiaphragm
  • Morbid obesity
  • Claustrophobia
  • Any condition in the PI's judgement which present unncessary risk
  • Lactating women
  • Subjects with hemoglobinopathies
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Related Publications (3)

  • 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
  • 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

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

February 22, 1999

Primary Completion

August 3, 2009

Study Completion

August 3, 2009

Last Updated

July 2, 2017

Record last verified: 2009-08-03

Locations