When were DaTscan (I-123 ioflupane SPECT/CT), DOPA PET (Positron Emission Tomography) scans, and TRODAT scans FDA-approved for clinical use in the United States?

FDA Approval Timeline for Dopamine Transporter Imaging

DaTscan (I-123 Ioflupane SPECT/CT)

DaTscan (I-123 ioflupane injection) received initial FDA approval in 2011 for striatal dopamine transporter visualization using SPECT brain imaging in adult patients with suspected Parkinsonian syndromes or suspected dementia with Lewy bodies. 1

• The FDA approved DaTscan as a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB) 1
• This approval followed multicenter clinical trials demonstrating high diagnostic accuracy, with positive percent agreement of 92-97% for abnormal scans in patients with PS and negative percent agreement of 74-96% for normal scans in patients with essential tremor 2
• The approval made DaTscan a covered service under Medicare policy in the United States 3

DOPA PET Scans

DOPA PET scans are not FDA-approved for routine clinical use in the United States and remain primarily research tools. 4, 5

• According to the American College of Radiology, DOPA PET is not available for routine clinical use in most U.S. centers 4
• If dopamine transporter imaging is needed clinically, DaTscan should be ordered specifically rather than DOPA PET 4
• DOPA PET remains an investigational imaging modality without FDA approval for clinical diagnostic purposes 4, 5

TRODAT Scans

TRODAT scans are not FDA-approved and are not available for routine clinical use in the United States. 4, 5

• The American College of Radiology confirms that TRODAT is not available for routine clinical use in most U.S. centers 4
• TRODAT remains a research imaging agent without FDA approval for clinical diagnostic applications 4
• When dopamine transporter imaging is clinically indicated, DaTscan is the only FDA-approved option available 4, 5

Clinical Context and Appropriate Use

DaTscan should only be ordered after MRI brain imaging and when clinical uncertainty persists regarding the diagnosis of Parkinsonian syndromes versus essential tremor or drug-induced parkinsonism. 4, 5

• The American College of Radiology recommends MRI brain without contrast as the optimal initial imaging modality before any nuclear medicine study 4, 5
• DaTscan is indicated specifically for differentiating true Parkinsonian syndromes from essential tremor and drug-induced tremor, but cannot differentiate between different types of Parkinsonian syndromes 4, 5
• DaTscan is not indicated for monitoring disease progression in established Parkinson's disease 4
• The diagnosis of Parkinsonian syndromes should be confirmed by general neurologists or movement disorder specialists, as correctly diagnosing a parkinsonian syndrome on clinical features alone can be quite challenging 5