GE Healthcare announced recently the availability of DaTscan™ (Ioflupane I 123 Injection), in more than 80 hospitals across the US. DaTscan is the first FDA-approved radiopharmaceutical adjunct imaging agent to help physicians evaluate patients with suspected parkinsonian syndromes (PS), such as Parkinson’s disease.
Parkinsonian syndrome occurs when certain neuronal pathways in the brain are affected, including pathways involving dopamine. This affects the ability of the brain to control movement and other muscle functions. DaTscan is an adjunct to other diagnostic evaluations to help differentiate essential tremor – a common movement disorder – from tremors due to PS. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.
In Europe, DaTscan is also approved to help differentiate between dementia with Lewy bodies (DLB) and Alzheimer’s disease. A diagnosis of “probable DLB” requires dementia plus any two symptoms from the following list: fluctuating cognition, recurrent visual hallucinations, parkinsonism, REM sleep behavior disorder, severe neuroleptic sensitivity, or low dopamine transporter update in the basal ganglia demonstrated by SPECT or PET imaging.
Because DaTscan is a Drug Enforcement Administration (DEA) Schedule II controlled substance, hospitals and nuclear imaging centers that administer DaTscan must have infrastructure dedicated to quality control, handling and dispensing of DEA Schedule II, radioactive drugs used for diagnosis and treatment.