Examination of the Hemodynamics of the Portal Venous System in Normal Volunteers Using Magnetic Resonance Imaging
Data Collection
Digestive System Diseases
+ Liver Diseases
Summary
Study start date: August 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps