NCT00001719

Brief Summary

This study will use magnetic resonance imaging (MRI) to examine blood flow patterns in the arteries and veins of the liver and abdomen. It will 1) determine the best way to measure blood flow in these vessels, and 2) make detailed measurements of the blood flow patterns of these vessels. Information about normal liver blood flow may help explain the role of blood flow in liver disease. Normal healthy volunteers 18 years of age and older may be eligible for this study. They will undergo MRI-a diagnostic tool that uses a strong magnetic field and radio waves to show structural and chemical changes in tissue and the speed of moving blood. The patient lies on a stretcher inside a metal cylinder (the scanner) for 1 to 1.5 hours and will be required to lie very still for 10 to 15 minutes at a time. Blood pressure, heart rate, breathing and the amount of oxygen in the fingertip are measured during the scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 1998

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

August 1, 1998

Completed
1.3 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
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Blood FlowHepatic DiseaseLiverModelingRheologyNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Normal adult volunteers in good health with no history of liver disease or alcohol abuse - minimum age: 18 years.
  • Physically able to tolerate lying within the bore of the magnet for 1-2 hours (usual study is expected to last approximately 1-1.5 hours).
  • Subjects should not be claustrophobic.
  • Normotensive: Upper limit of Systolic Blood Pressure 140 mm Hg; Upper limit of Diastolic Blood Pressure 90 mm Hg.
  • No known history of vascular disease, including but not limited to the presence of cardiovascular risk factors such as smoking, or if receiving vasoactive medications such as for treatment of hypertension.
  • Weight range: 120 lbs. to 250 lbs.
  • Not pregnant. If a female subject is in her child bearing years and at risk for pregnancy, subject must be using a reliable birth control method and must be within two weeks of the onset of the last menstrual period/
  • No relative or specific contraindications for MRI exam: including, but not limited to, metal objects in the body such as pacemakers, aneurysm clips, cochlear implants, metallic implants (orthopedic appliance, artificial cardiac valve) or shrapnel. Subjects whose occupation places them at risk of having unsuspected metal fragments in the eye, such as welders and metal workers, will be excluded,
  • No known hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Torres WE, Whitmire LF, Gedgaudas-McClees K, Bernardino ME. Computed tomography of hepatic morphologic changes in cirrhosis of the liver. J Comput Assist Tomogr. 1986 Jan-Feb;10(1):47-50. doi: 10.1097/00004728-198601000-00009.

    PMID: 3944316BACKGROUND
  • Shiomi S, Kuroki T, Miyazawa Y, Ueda T, Takeda T, Nishiguchi S, Nakajima S, Kobayashi K, Ochi H. Hepatic distribution of blood flow from the superior or inferior mesenteric vein mapped by portal scintigraphy with iodine-123-iodoamphetamine. J Nucl Med. 1996 Jan;37(1):51-4.

    PMID: 8544002BACKGROUND
  • Jones EC, Chezmar JL, Nelson RC, Bernardino ME. The frequency and significance of small (less than or equal to 15 mm) hepatic lesions detected by CT. AJR Am J Roentgenol. 1992 Mar;158(3):535-9. doi: 10.2214/ajr.158.3.1738990.

    PMID: 1738990BACKGROUND

MeSH Terms

Conditions

Liver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1998

Study Completion

August 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-08

Locations