Pediatric
Advisory Subcommittee Meeting
Open Meeting
February 3
& 4, 2004
Draft
Questions
1. Given the differences in
cardiac disease processes that occur in adults and children, in what cases (if
any) can adult data from approved imaging drugs be extrapolated to pediatric
patients in whom cardiac imaging is needed?
If so, in what cardiac disease states?
2. Assuming further studies in
pediatric patients are needed, we would like you to further define the gaps in
our knowledge regarding imaging agents to be evaluated for cardiac imaging
applications.
Please discuss each of the following questions for
each imaging modality (cardiac CT, cardiac MRI, cardiac US, and cardiac nuclear
imaging)
a) What imaging agents need
further study?
b) What populations should be
studied?
c) What disease states should
be studied?
d) What endpoints should be
used?
e) How should a trial be
designed?
f) How should the standard for
comparison be defined? Is there a
gold-standard?
3. Are there new developments
in the field of adult cardiac imaging that may have potential application to
the pediatric population? Can we
anticipate the need for future drug development for pediatric cardiac
imaging?