FDA Approves DATSCAN (ioflupane I-123) for Striatal Dopamine Transporter Visualization in Suspected Parkinsonian Syndromes or Dementia with Lewy Bodies
The FDA has approved DATSCAN (ioflupane I-123), a radioactive diagnostic agent, for use as an adjunct to other diagnostic evaluations in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). This approval provides clinicians with a tool for striatal dopamine transporter visualization via single photon emission computed tomography (SPECT) brain imaging, which can help in the assessment of these neurodegenerative disorders. The agent is administered intravenously, with imaging conducted 3 to 6 hours post-injection, and requires thyroid blockade prior to use to minimize radiation exposure. This approval addresses a need for additional diagnostic support in differentiating PS and DLB from other conditions with similar symptoms, though it is not a standalone diagnostic and must be integrated with clinical evaluations.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).
Administer a thyroid-blocking agent (e.g., Potassium Iodide Oral Solution or Strong Iodine Solution equivalent to 100 mg iodide) at least one hour before DATSCAN. The recommended dose is 111 MBq to 185 MBq (3 mCi to 5 mCi) administered intravenously over at least 20 seconds. Measure the dose using a dose calibrator immediately prior to administration. Begin SPECT imaging between 3 hours and 6 hours post-injection. Use aseptic procedures and radiation shielding during preparation and administration. Inspect the vial for particulate matter and discoloration before use; do not use if present. Discard unused portion. Encourage hydration and frequent voiding for 48 hours post-administration to minimize radiation exposure.
trial data not available in label
DATSCAN emits radiation and must be handled with safety measures to minimize exposure to healthcare providers and patients. Use by or under control of qualified healthcare providers trained in radionuclide handling. Administer thyroid blockade to prevent iodine-123 uptake by the thyroid. Assess pregnancy status before administering to females of reproductive potential. Not reported in label for specific contraindications.
DATSCAN is used as an adjunct to other diagnostic evaluations for visualizing striatal dopamine transporters in adult patients with suspected PS or DLB. It aids in the diagnostic process but does not replace clinical assessment or other evaluations. Image interpretation is based on visual assessment of striatal appearance in SPECT images, without integration of clinical signs or symptoms.
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