Drug updated on 9/5/2024
Dosage Form | Injection (intravenous; 74 MBq/mL [2 mCi/mL]) |
Drug Class | Radioactive diagnostic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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)
- 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 dementia with Lewy bodies (DLB)
Latest News
Summary
- Datscan (ioflupane I-123) 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) and 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 dementia with Lewy bodies (DLB).
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Dopamine transporter SPECT using iodine-123 (I-123) ioflupane (DaTscan) was effective in differentiating parkinsonian syndromes due to nigrostriatal degeneration from other clinical mimics, particularly in cases where clinical criteria were unclear.
- DaTscan imaging resulted in changes in clinical management in 54% (95% CI: 47-61%) of patients and altered diagnosis in 31% (95% CI: 22-42%) of cases, demonstrating its significant role in clinical decision-making across varied timeframes from symptom onset.
- Transcranial Sonography (TCS) and DaTscan had nearly similar sensitivity and specificity in differentiating Parkinson’s disease (PD) from essential tremor (ET), with TCS showing a pooled sensitivity of 84.6% (95% CI: 79.4-88.6%) and specificity of 83.9% (95% CI: 78.4-88.2%).
- There is no safety information available in the reviewed studies.
- The reviewed studies involved a general patient population suspected of parkinsonian syndromes and essential tremor, with specific subgroup analyses comparing the diagnostic effectiveness of DaTscan and TCS in distinguishing Parkinson’s disease from essential tremor, demonstrating high diagnostic accuracy for both tools across these groups. Additionally, DaTscan significantly influenced clinical management and diagnosis, particularly in patients with suspected parkinsonian syndromes, with changes in management observed in 54% (95% CI: 47-61%) of patients and changes in diagnosis in 31% (95% CI: 22-42%) of patients.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
DaTscan (ioflupane I-123) Prescribing Information. | 2022 | GE Healthcare, Arlington Heights, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Practical Overview of 123I-Ioflupane Imaging in Parkinsonian Syndromes. | 2024 | Radiographics |
Differentiating Parkinson's Disease from Essential Tremor Using Transcranial Sonography: A Systematic Review and Meta-Analysis. | 2022 | Journal of Parkinson’s Disease |
Clinical utility of DaTscan in patients with suspected Parkinsonian syndrome: A systematic review and meta-analysis. | 2021 | NPJ Parkinson’s Disease |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
CANM guidelines for imaging of the dopamine transport system in evaluation of movement disorders. | 2020 | The Canadian Journal of Nuclear Medicine |
EANM practice guideline/SNMMI procedure standard for dopaminergic imaging in Parkinsonian syndromes 1.0. | 2020 | European Journal of Nuclear Medicine and Molecular Imaging |
Canadian guideline for Parkinson disease – Executive summary. | 2019 | Canadian Medical Association Journal |
Canadian guideline for Parkinson disease. | 2019 | Canadian Medical Association Journal |