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Magnetic Resonance Imaging (MRI) of Normal Volunteers

This study is currently recruiting participants.
Study NCT00001711.   Last updated on September 9, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Magnetic Resonance Imaging (MRI) of Normal Volunteers
Official Title  Normal Volunteer Scanning on MR
Brief Summary

Magnetic resonance is an imaging technique that uses magnetic fields and radio waves to create images of the body. The technology used in magnetic resonance imaging continues to improve. Advancements in magnetic resonance imaging (MRI) requires researchers to study new techniques in normal volunteers in order to understand how to use them in patients with diseases.

In this study researchers plan to do a variety of diagnostic tests including magnetic resonance imaging on normal volunteers. The studies may involve injections of contrast media, substances injected into the blood of participant that improves the image created by the MRI scanner. The study is not expected to benefit the participants. However, information gathered from the study may be used to improve diagnostic techniques and develop new research studies.

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Detailed Description

Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies may involve the intravenous administration of commercially available MR contrast media, glucagon or secretin, or an FDA approved microbubble contrast agent, Optison. Some scans may require gastrointestinal contrast such as water or dilute gadolinium or barium. We also use inhaled carbogen as a contrast media. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and rf coils on human subjects and will provide essential ground work for specific patient protocols.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Healthy
Intervention 
MEDLINE PMIDs 9393533,   1889423,   7928216
Links NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1000
Start Date  October 1997
Completion Date
Eligibility Criteria 
  • INCLUSION CRITERIA:

Any normal volunteer above the age of 18 who is capable of giving informed consent.

EXCLUSION CRITERIA:

A subject will be excluded if he/she has a contraindication to MR scanning such as surgery that involves metal clips or wires which might be expected to concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field. Examples include: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body (e.g., metal shavings), any implanted device (pumps, infusion devices, etc), shrapnel injuries.

For studies involving the use or Optison (microbubble contrast agent), subjects will be excluded if they have severe liver or lung disease, congenital heart defects, history of pulmonary emboli, or known or suspected hyper-sensitivity (allergic reaction) to blood, blood products or albumin.

For studies involving the injection of Gadolinium based contrast a serum Creatinine obtained within one week of the MRI examination. All subjects with a calculated eGFR greater than 60 will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non contrasted MRI studies.

Subjects will be excluded if it is deemed that they have a condition which would preclude their use for technical development (e.g., paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.) or present unnecessary risks (e.g. pregnancy, surgery of uncertain type, symptoms of pheochromocytoma or insulinoma, etc.) Lactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the administration of contrast agents.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001711
Organization ID 980019
Secondary IDs †† 98-CC-0019
Study Sponsor  National Institutes of Health Clinical Center (CC)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date August 2008
First Received Date  November 3, 1999
Last Updated Date September 9, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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