HealthyNCT00001719
Magnetic Resonance Imaging of Blood Flow in the Liver and Abdomen
An observational study of Healthy and Liver Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Liver Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Aug 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Examination of the Hemodynamics of the Portal Venous System in Normal Volunteers Using Magnetic Resonance Imaging
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.
Read the 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.
- Conditions
- Healthy, Liver Disease
- Keywords
- Blood Flow, Hepatic Disease, Liver, Modeling, Rheology, Normal Volunteer
- Medical subject headings
- Liver Diseases, Digestive System Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1998
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001719
- Sponsor's protocol ID
- 980148
- Other IDs
- 98-CC-0148
- Status last verified
- Aug 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 3944316Shiomi 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.
PubMed 8544002Jones 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.
PubMed 1738990
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Hemodynamics of the Portal Venous System in Normal Volunteers Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00001719
- Acronym / sponsor ID
- 980148
- Conditions
- Healthy, Liver Disease
- Keywords
- Blood Flow, Hepatic Disease, Liver, Modeling, Rheology, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Aug 1998
- Study completion
- Aug 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3944316Torres 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.
- Background: PubMed 8544002Shiomi 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.
- Background: PubMed 1738990Jones 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Liver Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001719, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.