A pooled analysis of four clinical trials, presented recently at the American Academy of Neurology’s 66th Annual Meeting, indicates that using DaTscan (Ioflupane I 123 Injection) with single-photon emission computed tomography (SPECT) brain imaging is associated with a high level of diagnostic effectiveness.
DaTscan, a trademark of GE Healthcare, is a radiopharmaceutical approved in the United States for striatal dopamine transporter visualization, using SPECT brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS) to help differentiate PS from essential tremor (ET).
The analysis, sponsored by GE Healthcare, showed that across the four studies, images assessed by on-site readers demonstrated an overall sensitivity of 91.9% and specificity of 83.6%. When images were assessed blindly by a panel of independent experts, the overall sensitivity was 88.7% and specificity was 91.2%.
In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported, and in postmarketing experience, hypersensitivity reactions, and injection site pain have been reported. DaTscan are considered adjuncts to other diagnostic evaluations.
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