European database of [123I]FP-CIT (DaTSCAN) SPECT scans of healthy controls (ENC-DAT)

Nowadays, it is feasible to detect or exclude dopaminergic degeneration in
humans in vivo with the registered radioligand [123I]FP-CIT (DaTSCAN) and
SPECT. Since several years, FP-CIT SPECT can be used routinely to differentiate
disorders characterized by dopaminergic degeneration (e.g., Parkinson*s
disease; PD) from disorders not characterized by degeneration (e.g., essential
tremor), but which could show some overlap in clinical symptomatology. Recently
the technique has been registered to differentiate dementia with Lewy bodies
from Alzheimer*s disease.
In routine clinical studies, FP-CIT SPECT scans are often evaluated visually.
However, a few studies showed that a quantitative assessment may be more
adequate. To perform a quantitative analysis it is essential, however, to have
entry to a database of normal reference data. Ideally, these data will be
obtained in a large group of healthy volunteers. However, for the majority of
departments that use FP-CIT SPECT routinely, it is not feasible to build a huge
database on there own and fast. This problem has been recognized by the
European Association for Nuclear Medicine (EANM). Recently, the neuroimaging
committee of the EANM has taken the initiative to build up a database in a
collaboration of 15 European institutes, including the AMC. The aim of this
collaboration is to build up the database (n=175), which will be available for
all departments that are using FP-CIT SPECT for routine clinical studies. The
big advantage of this approach it that, because a large group of institutes
support this initiative (15 in total), a relative small group of volunteers has
to be scanned within each institute to build up a large and well-documented
database over a reasonable time.

The ultimate goal is to build a large, well-documented, database of normal
FP-CIT data obtained in healthy volunteers. For this purpose, in a large number
of European institutes we will obtain in, minimal 10 and maximal 15 healthy
volunteers per center, two FP-CIT SPECT scans per participant.

Normal FP-CIT data will be obtained in healthy volunteers. For this purpose, in
a large number of European institutes we will obtain in, minimal 10 and maximal
15 healthy volunteers per center, two FP-CIT SPECT scans per participant.

The burden for each participant consists of exposures to each of the following:
one [123I]FP-CIT injection (2 SPECT scans will be obtained after injection),
one standard MRI scan, one neurological and neuropsychiatric examination, and
delivery of one urine specimen (to exclude recent use of drugs of abuse). For
females from child bearing age, a urine test will be performed to exclude
pregnancy.
The risks for the participants are: radiation burden (within the WHO criteria
for research in human).