search
Back to results

Magnetic Resonance Imaging of Blood Flow in the Liver and Abdomen

Primary Purpose

Healthy, Liver Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Healthy focused on measuring Blood Flow, Hepatic Disease, Liver, Modeling, Rheology, Normal Volunteer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA 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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001719
Brief Title
Magnetic Resonance Imaging of Blood Flow in the Liver and Abdomen
Official Title
Examination of the Hemodynamics of the Portal Venous System in Normal Volunteers Using Magnetic Resonance Imaging
Study Type
Observational

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.
Detailed Description
The involvement of the liver by certain disease processes is non-uniform and may be related to hepatic anatomy and the dynamics of portal blood flow. These differences may result from inhomogeneous delivery of hepatic toxins or trophic substances, tumor secretion products or tumor metastases to different portions of the liver. In addition to effects on the natural history of hepatic disease, these features may affect the performance (planning/methods) and interpretation of diagnostic studies, such as hepatic venous sampling for measurement of tumor secretion products. This study will combine non-invasive quantitative in vivo measurements of blood flow with in vitro modeling of the vascular system. The purpose of the study is to define the normal hemodynamics of hepatic blood flow, particularly portal flow, using Magnetic Resonance Angiography (MRA) and to draw inferences regarding the role of hemodynamics in the natural history of hepatic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Liver Disease
Keywords
Blood Flow, Hepatic Disease, Liver, Modeling, Rheology, Normal Volunteer

7. Study Design

Enrollment
50 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3944316
Citation
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.
Results Reference
background
PubMed Identifier
8544002
Citation
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.
Results Reference
background
PubMed Identifier
1738990
Citation
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.
Results Reference
background

Learn more about this trial

Magnetic Resonance Imaging of Blood Flow in the Liver and Abdomen

We'll reach out to this number within 24 hrs