Fwd: Re: Off-label Use of IVB devices

[Chris Alston <alstonc@odrge.odr.georgetown.edu>]

>Reply-To: Joerg Lehmann <joerg@REYES.STANFORD.EDU>
>
>
>I don't have THE answer but a couple thoughts about your situation
>
> >We are preparing for our first clinical IVB cases in cardiology using
>Ir-192
> >and Sr-90.  I have been providing guidance to an AU who is preparing a
> >sub-license amendment request.  One issue that has come up is off-label
>use.
>
>I would be VERY careful with this.
>
> >A representative from one vendor has suggested that off-label use will
>be a
> >common occurrence and no big deal.  (Our Cardiologist's whole-heartedly
>
> >agreed).
>
>Well, the cardiologists are not responsible for the administration of
>the radiation, the Radiation Oncologist is.
>And I really dislike the attitude of the vendor representative. It
>almost sounds like he is encouraging you to use the device for ANYTHING.
>Again, be careful, anything you do "off-label" is your responsibility.
>The field is very exciting and promising, but still new.
>
> >sublicense.)  Examples could be stepping the source train to treat a
>longer
> >lesion length than indicated, or application to a non-stented artery.
>
>I would discourage you to do any manual stepping with the Sr-90 system.
>According to Monte Carlo simulations, that I did some time ago, small
>gaps (1..2 mm) between the steps can already cause significant cold
>spots (dose <50%).
>
>Good luck, ... and please keep us current about the "suggestions" of the
>vendor.
>(We are about to start using the Sr-90 system as well, but no off-label
>use is intended by our cardiologists.)
>
>Joerg
>
>---------------------------------------------------------
>Joerg Lehmann, Ph.D.
>Department of Radiation Oncology
>Stanford University School of Medicine


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