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GE Healthcare announces
clinical trial and study to aid evaluation of
patients with suspected parkinsonian syndromes |
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First patient dosed in Phase III clinical trial for a new PET radiopharmaceutical |
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Next stage clinical study also proceeding for a new SPECT radiopharmaceutical |
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Both imaging agents aim to assist in the evaluation of adult patients with suspected parkinsonian syndromes, support research and improve patient care |
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Builds on market leadership with SPECT agent DaTscan™ (Ioflupane I 123 Injection), to offer increased choice for nuclear medicine community
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Learn about the Phase III clinical trial for a new PET radiopharmaceutical |
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"Having a PET option for dopamine transporter imaging in patients with parkinsonian syndromes could be highly relevant for an early differential diagnosis."
–Professor Olivier Rascol
Clinical Pharmacology
Toulouse University Hospital |
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| Learn about the next stage clinical study proceeding for a new SPECT radiopharmaceutical |
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| "This new SPECT agent may offer a faster imaging workflow which could provide more convenience for patients with suspected parkinsonian syndromes and greater efficiency for the imaging clinic. It also holds promise in potentially making dopamine transporter imaging more accessible if approved." |
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–Dr. John Seibyl
Board Chairman and Distinguished Scientist
Institute for Neurodegenerative Disorders, New Haven, Connecticut |
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| PRODUCT INDICATION AND USE |
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DaTscan™ (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal
dopamine transporter visualization using single-photon emission computed
tomography (SPECT) brain imaging to assist in the evaluation of adult patients with
suspected parkinsonian syndromes (PSs). In these patients, DaTscan may be used
to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's
disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy
[PSP]). DaTscan is an adjunct to other diagnostic evaluations. |
| DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established. |
IMPORTANT SAFETY INFORMATION ABOUT DATSCAN™
(IOFLUPANE I 123 INJECTION) |
| CONTRAINDICATIONS |
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DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine |
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| ADVERSE REACTIONS |
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In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported |
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For additional important safety information, please see Full Prescribing
Information for DaTscan available here. |
GE, 2022
GE and the GE Monogram are trademarks of GE. |
| March 2022 JB06680US |
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