The Food and Drug Administration (FDA) has expanded the approval of DaTscan (ioflupane I 123 injection) for use in adults with suspected dementia with Lewy Bodies (DLB) as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. DaTscan is also indicated for use in adults with suspected parkinsonian syndromes.

DaTscan is a radioactive diagnostic agent that works by binding reversibly to the human dopamine transporter (DaT) in the brain. Following administration of DaTscan, radioactive decay of the iodine-123 emits gamma radiation allowing for visualization of the brain striata through SPECT imaging.

The approval of DaTscan in visualizing striatal dopamine transporters in adult patients with DLB was based on a compilation of data that included an analysis of 55 adults diagnosed with DLB or with Alzheimer disease. DaTscan images were compared with neuropathological diagnosis made using standard international criteria at autopsy. Based on autopsy diagnosis, findings showed that the sensitivity and specificity of DaTscan for DLB was 80% (95% CI, 61-92) and 92% (95% CI, 74-99), respectively. 

“More than one million doses of DaTscan have already been used around the world in the clinical evaluation of parkinsonian syndromes,” said Mark Hibberd, Chief Medical Officer for GE Healthcare Pharmaceutical Diagnostics. “We have built on our scientific and medical leadership with DaTscan to pave the path for this new indication that supports our customers and their patients with more accurate diagnoses of DLB.”

References

  1. Datscan (Ioflupane I 123 Injection) indication expanded to include use in patients with suspected Dementia with Lewy Bodies (DLB). News release. GE Healthcare. Accessed November 3, 2022. https://www.businesswire.com/news/home/20221103005731/en/DATSCAN%E2%84%A2-Ioflupane-I-123-Injection-indication-expanded-to-include-use-in-patients-with-suspected-Dementia-with-Lewy-Bodies-DLB
  2. Datscan. Package insert. GE Healthcare; 2022. Accessed November 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454s010lbl.pdf