USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-95-112-H01

Project Title:

Pilot Study for In Vivo Sodium Content by MRI

Principle Investigator: Mr. Josh Lack

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Explanation:

Unfunded thesis research.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: February 17, 1995
IRB Approval Number: 95-2-118

Number of Human Subjects in the Last Reporting Period for this Project: 2
(Reporting periods vary.)

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

To show that the evaluation of real-time sodium concentration in living tissues is possible through the use of a new magnetic resonance imaging (MRI) technique. Images generated with this new technique, called "short and long T2 imaging" will be compared to standard MRI images. In vivo sodium level fluctuations may be significant in heart disease and other conditions involving muscle contraction.

The risks of MRI include the possibility of discomfort associated with holding the arm still for a long period of time. The new technique poses no more risk than standard MR imaging.