Changes in Clinical Management and Diagnosis following DaTscan™ SPECT Imaging in Patients with Clinically Uncertain Parkinsonian Syndromes: A 12-Week Follow-Up Study

Abstract

Background: An accurate diagnosis is important for timely and adequate treatment in patients with clinically uncertain parkinsonian syndrome (CUPS). Objective: The objective of this study was to assess safety and changes in clinical management, diagnosis and quality of life (QoL) at 4 and 12 weeks following DaTscan™ (ioflupane [¹²³I] injection) imaging in patients with CUPS. Methods: This randomized, open-label, single-dose, multicenter trial was carried out in patients with CUPS who were randomized to either a DaTscan imaging group or to a control group without imaging. The main outcome measures were the proportions of patients with changes in clinical management and diagnosis from baseline through to 12 weeks after DaTscan. A total of 19 university hospital centers in Europe and the USA participated in the study. There were 267 patients enrolled and randomized (131 DaTscan, 136 control). Results: Significantly more DaTscan patients had changes in clinical management after 12 weeks (p = 0.004) compared to the control group, and significantly more DaTscan patients had changes in diagnosis at 4 weeks and at 12 weeks (both p < 0.001) compared to control patients. No significant difference in total score for QoL was observed between groups during the study duration. DaTscan was safe and well-tolerated. No deaths, serious adverse events (AEs) or withdrawals due to AEs occurred during the study. One patient had a headache following treatment with a suspected relationship to DaTscan. Conclusion: DaTscan imaging significantly affected the clinical management and diagnosis of patients with CUPS. DaTscan is safe and well-tolerated and is a useful adjunct to differential diagnosis of CUPS.

Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study

“…Following an interim analysis of our data, we previously reported that significantly more patients in the DaTscan group had a change in their clinical management at approximately 12 weeks post-treatment compared with patients in the control group 25. Similar results were obtained at 1-year follow-up, with significantly more patients in the DaTscan group (41%) having a change in clinical management compared with the control group (22%).…”

Positron Emission Tomography Applications in Clinical Neurology

“…31 A presynaptic single photon emission computed tomography (SPECT) agent for dopamine transporter has been recently approved for clinical use to distinguish Parkinson's disease from essential tremor based on preserved uptake of the tracer in the latter. 32 Similar results with corresponding dopamine transporter PET ligands are expected.…”

Clinical Impact of ¹²³I-Ioflupane SPECT (DaTscan) in a Movement Disorder Center

“…Other studies have shown a change in clinical management after imaging in 50% [8], 63% [2], and 72% [9] of all cases. Here, we expand upon these prior studies by assessing quantitative estimates of diagnostic certainty before and after imaging and by assessing the degree to which the asymmetry in the results corresponds to asymmetric symptoms in the clinical examination.…”