SimonMed Announces Offering of DaTscan

SCOTTSDALE, Ariz., April 24, 2023 /PRNewswire/ -- SimonMed is proud to announce we will offer GE HealthCare's radiopharmaceutical diagnostic tracer, DaTscan™ (Ioflupane I 123 injection), with DaTQUANT™ nationally starting immediately in all of our markets.

DaTscan was recently approved by the U.S. Food and Drug Administration (FDA) for an expanded label which includes use in patients with suspected Dementia with Lewy Bodies (DLB). The new indication is in addition to its use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes. With the expanded indication, DaTscan is now available to more patients, including those with suspected DLB, in the U.S.

Approximately one in five patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer's disease¹. The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer's disease². This new indication enables SimonMed clinicians to use DaTscan as part of their diagnostic workup to help differentiate DLB from other forms of dementia. Early and accurate diagnosis of DLB can help ensure specific appropriate treatment and specialized care for patients, while enabling them and their caregivers to more effectively manage the disease and plan for the future³.

John P. Uglietta, MD, Emeritus Medical Director of Neuroradiology at SimonMed Imaging (SMI) said: "SimonMed is the National Leader in imaging patients with movement disorders having done more DaTscans than any other single medical entity in the country. Additionally, SMI was an early adopter of using DaTQUANT as a quantitative objective tool to aid in the visual interpretation of DaTscan to improve accuracy and diagnostic confidence over visual interpretation alone. Today, we are the largest specialty outpatient radiology practice in the US utilizing DaTscan with DaTQUANT and we have standardized our protocol to include DaTQUANT with every DaTscan ordered across all of our National imaging centers. The extensive experience of SimonMed Neuroradiologists interpreting DaTscans and FDG PET-CT scans of the brain significantly improves the confidence level of receiving an accurate diagnosis of Parkinson's related movement disorders and now offering improved accuracy of obtaining a confirmed diagnosis of DLB."

Amanda Hamilton, General Manager, Molecular Imaging of GE HealthCare's U.S Pharmaceutical Diagnostics division said: "We are pleased to support our longstanding customer SimonMed in their efforts to offer broad access to leading-edge diagnostic Neuroimaging options for clinicians and their patients. Our expanded DaTscan label is an example of GE HealthCare's commitment towards advancing the future of Molecular Imaging through research and innovation, by delivering products and solutions that help empower better patient care and outcomes. We look forward to our continued collaboration with SimonMed including potential future clinical studies for new SPECT imaging agents and new PET-CT agents."

About SimonMed Imaging

Headquartered in Scottsdale, Arizona, SimonMed is one of the largest independent outpatient medical imaging providers and physician radiology practices in the United States. SimonMed has 147 sites across 11 states and nearly 200 subspecialty-trained radiologists. SimonMed Imaging offers the full modality of diagnostic scans, including 3T MRI, CT, ultrasound, 3-D mammography, PET/CT, nuclear medicine, DEXA, X-rays, among others. The company uses the newest, most-advanced, diagnostic imaging technologies while maintaining affordability and accessibility. SimonMed is a worldwide leader in the clinical use of AI to improve diagnoses with one of the largest global deployments to enhance early breast cancer detection and in the evaluation of brain disorders. Through its simonONE division, SimonMed is also at the forefront of personalized imaging for the early diagnosis and treatment of disease. For more information, visit www.simonmed.com.

References:

¹ Barker, Warren W et al. "Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank." Alzheimer disease and associated disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001

² Warr et al. Q J Nucl Med Mol Imaging; 2012; 56: 39-54

³ Zweig and Galvin Alzheimer's Research & Therapy 2014, 6.21; http://alzres.com/content/6/2/21

Product Indications and Important Safety Information – DaTscan

PRODUCT INDICATION AND USE

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).

Important Safety Information About DaTscan™ (ioflupane I 123 injection)

CONTRAINDICATIONS

• DaTscan is contraindicated in patients with known serious hypersensitivity to ioflupane I 123.

WARNINGS AND PRECAUTIONS

• Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following DATSCAN administration.
• Thyroid Accumulation: DaTscan may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of iodine-123, block the thyroid gland before administration of DaTscan.

ADVERSE REACTIONS

• 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

DRUG INTERACTIONS

• Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established

USE IN SPECIFIC POPULATIONS

• Pregnancy: Radioactive iodine products cross the placenta and can permanently impair

fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of DaTscan in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on DaTscan use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant woman of the potential risks of fetal exposure to radiation with the administration of DaTscan

Product Indications and Important Safety Information – DaTscan

• Lactation: Iodine 123 (I 123), the radionuclide in DaTscan, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after DaTscan administration to minimize radiation exposure to a breastfeeding infant
• Pediatric Use: The safety and efficacy of DaTscan have not been established in pediatric patients
• Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies.
• Renal Impairment: DaTscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered DaTscan images

OVERDOSAGE

• The risks of overdose relate predominantly to increased radiation exposure, with the long-term risks for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.

PROCEDURE — Radiation Safety

• DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients

Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

SOURCE SimonMed Imaging