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gregory.mccarthy
BIAC Alum
USA
26 Posts |
 Posted - May 10 2005 : 09:05:08 AM
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Dear BIAC Investigator:
As you know, the BIAC decommissioned its 1.5 Tesla General Electric MRI scanner this past March 2005. We are now in the process of installing a 3.0 Tesla GE MRI system. This system was delivered in April 2005 and is planned to be ramped to field on May 17th. It is scheduled to be turned over to BIAC for routine use on June 1st, although it may take additional time for all experimental sequences to be tested.
If your current IRB protocol specifies the old 1.5 Tesla BIAC scanner, then this will need to be amended by the IRB before you can use the new 3.0 Tesla system. It is my understanding that these protocols can be reviewed in an expedited manner, but that is the decision of the IRB chair, not the BIAC.
In preparing your amendment, you should know the following. The FDA has approved MRI scanners up to and including 3.0 Tesla for routine clinical studies in all age groups, and the GE 3.0 Tesla scanner that we purchased is FDA approved. When operated within FDA guidelines for specific absorption rate (SAR), change in gradient strength (db/dT), and sound levels, the FDA has also declared research studies with field strengths up to and including 7.0 Tesla as non-significant risk (NSR). As BIAC’s pulse sequences are kept below the FDA limits on SAR and db/dT, and as GE’s sound levels meet FDA guidelines, research studies on the new 3.0 Tesla meet the FDA guidelines for NSR. However, it is ultimately the IRB’s decision as to whether your particular study is designated NSR. You may wish to attach this memo to your IRB amendment to help convey the relevant facts concerning this transition.
The 3.0 Tesla system is a state-of-the-art multi-channel system with improved gradients running on the new GE Excite platform. Once the research pulse sequences are installed and tested in June, we expect that many current 4.0 Tesla users will consider switching to this system. BIAC encourages its investigators to consider using this new system, but you must first amend your IRB protocols and provide BIAC a copy of the approved amendment before you can schedule.
Sincerely,
Gregory McCarthy
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Edited by - gregory.mccarthy on May 10 2005 11:35:20 AM |
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IRB Amendments for 3.0 Tesla scanner
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