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Sm-153 marrow dose

> 4. Neither radiopharmaceutical requires dose rate determination for
patient
> release.
> 5.  Excellent information (package insert, dosage guide, patient
> instructions, administration hints, technical data sheet) may be download
> from Dupont's Quadramet website:

I am hearing from people that at least for radiolabeled antibodies, the FDA
will be soon wanting to see dose calculations for marrow that are
region-specific (i.e. dose to various regions of the marrow, and perhaps
dose-volume histograms (DVHs) in lieu of just mean marrow dose).  This
information has been routinely provided in the MIRDOSE software since its
release in the mid 1990's (based on the bone and marrow model developed by
Keith Eckerman of ORNL). I don't know if they'll be wanting the same type of
info for bone pain palliation agents, but it would be reasonable to assume
that they might.  I think this approach makes sense, as use of the regional
dose models, although they still come from a model that represents a
standard adult male or female, yield much more information than just the
mean marrow dose. An interesting paper on the use of DVHs in therapy with
Ho-166 was presented at the Nuclear Medicine meeting a couple of weeks back,
and it did seem to help in interpretation.

Interestingly, at the same time, the FDA has shut down distribution of
MIRDOSE (see J Nucl Med 41(6):13N) pending evaluation of the software as a
"medical device", so I don't know how physicians and physicists would supply
this information if they can't use the software. We are trying to get this
resolved. The whole issue of what software can and cannot be distributed, if
it has potential medical applications, appears to be pretty hard to nail
down.


Michael Stabin, PhD, CHP
Departamento de Energia Nuclear/UFPE
Av. Prof. Luiz Freire, 1000 - Cidade Universitaria
CEP 50740 - 540
Recife - PE
Brazil
Phone 55-81-271-8251 or 8252 or 8253
Fax  55-81-271-8250
E-mail stabin@npd.ufpe.br

"Quantum Mechanics: The dreams stuff is made of"
- Steven Wright


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