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Neurodegeneration

  • Neuraceq – Beta Amyloid Imaging
    • Bullich et al. (2021) Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6. Click here to access the pdf
    • de Wilde et al. (2018) Association of Amyloid Positron Emission Tomography With Changes in Diagnosis and Patient Treatment in an Unselected Memory Clinic Cohort: The ABIDE Project. JAMA Neurol. 2018 Jun 11. doi: 10.1001/jamaneurol.2018.1346. Click here to access the pdf
    • Ceccaldi et al. (2018) Added value of 18F-florbetaben amyloid PET in the diagnostic workup of most complex patients with dementia in France: A naturalistic study. Alzheimers & Dementia, Mar;14(3):293-305. doi: 10.1016/j.jalz.2017.09.009. Click here to access the pdf
    • Sabbagh MN et al. (2017) Histopathology and Florbetaben PET in Patients Incorrectly Diagnosed with Alzheimer’s Disease. J Alzheimers Dis. 2017;56(2):441-446. doi: 10.3233/JAD-160821. https://pubmed.ncbi.nlm.nih.gov/27983552/
    • Seibyl et al. (2016) Impact of Training Method on the Robustness of the Visual Assessment of 18F-Florbetaben PET Scans: Results from a Phase-3 Study. J Nucl Med. 2016 Jun;57(6):900-6. Click here to access the pdf
    • Sabri et al. (2015) Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer’s disease: phase 3 study. Alzheimers Dement. 2015 Aug;11(8):964-74. Click here to access the pdf
  • 18F-PI-2620 – Tau Imaging
    • “Bullich et al. Evaluation of tau deposition using 18 F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study“ Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x. Click here to acced the pdf
    • Rullmann M et al. (2022) Multicenter 18F-PI-2620 PET for In Vivo Braak Staging of Tau Pathology in Alzheimer’s Disease. Biomolecules. 2022 Mar 16;12(3):458. doi: 10.3390/biom12030458. Click here to access the pdf
    • Song et al. (2021) Feasibility of short imaging protocols for [18F]PI-2620 tau-PET in progressive supranuclear palsy. Eur J Nucl Med Mol Imaging. 2021 May 22. doi: 10.1007/s00259-021-05391-3. Click here to access the pdf
    • Palleis et al. (2021) Cortical [18 F]PI-2620 Binding Differentiates Corticobasal Syndrome Subtypes. Mov Disord. 2021 May 5. doi: 10.1002/mds.28624. https://pubmed.ncbi.nlm.nih.gov/33951244/
    • Brendel et al. (2020) Assessment of 18F-PI-2620 as a Biomarker in Progressive Supranuclear Palsy. JAMA Neurol. Published online July 07, 2020. Click here to access the pdf
    • Mormino et al. (2020) Tau PET imaging with 18F-PI-2620 in aging and neurodegenerative diseases. Eur J Nucl Med Mol Imaging. 2020 Jun 23 Online first Click here to access the pdf
    • Beyer et al. (2020) Early-phase 18F-PI-2620 tau-PET imaging as a surrogate marker of neuronal injury” Eur J Nucl Med Mol Imaging. 2020 Apr 21 Online first Click here to access the pdf
    • Mueller et al. (2020) Tau PET imaging with 18F-PI-2620 in patients with Alzheimer’s disease and healthy controls: a first-in-human study. J Nucl Med. 2020 Jun;61(6):911-919. Click here to access the pdf
  • 18F-DED – MAO-B Imaging

    • Nag et al. (2016) In Vivo and In Vitro Characterization of a Novel MAO-B Inhibitor Radioligand, 18F-Labeled Deuterated Fluorodeprenyl. J Nucl Med. 2016 Feb;57(2):315-20. doi: 10.2967/jnumed.115.161083. Click here to access the pdf

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Cardiovascular

  • Florbetaben – Cardiac Amyloid Imaging
    • Santarelli MF et al. (2021) Cardiac amyloidosis characterization by kinetic model fitting on [18F]florbetaben PET images. J Nucl Cardiol. 2021 Apr 16. doi: 10.1007/s12350-021-02608-8. https://pubmed.ncbi.nlm.nih.gov/33864226/
    • Santarelli MF et al. (2021). Deep-learning-based cardiac amyloidosis classification from early acquired pet images. Int J Cardiovasc Imaging. 2021 Jul;37(7):2327-2335. doi: 10.1007/s10554-021-02190-7. https://pubmed.ncbi.nlm.nih.gov/33591476/
    • Genovesi D et al. (2021) [18F]-Florbetaben PET/CT for Differential Diagnosis Among Cardiac Immunoglobulin Light Chain, Transthyretin Amyloidosis, and Mimicking Conditions. JACC Cardiovasc Imaging. 2021 Jan;14(1):246-255. doi: 10.1016/j.jcmg.2020.05.031. Click here to access the pdf
    • Kircher M et al. (2019). Detection of cardiac amyloidosis with 18F-Florbetaben-PET/CT in comparison to echocardiography, cardiac MRI and DPD-scintigraphy. Eur J Nucl Med Mol Imaging. 2019 Jul;46(7):1407-1416. doi: 10.1007/s00259-019-04290-y. https://pubmed.ncbi.nlm.nih.gov/30798427/
    • Law WP et al. (2016) Cardiac Amyloid Imaging with 18F-Florbetaben PET: A Pilot Study. J Nucl Med. 2016 Nov;57(11):1733-1739. doi: 10.2967/jnumed.115.169870. Click here to access the pdf
  • 18F-GP1 – Thrombus Imaging
    • Bing R et al. (2021) 18F-GP1 Positron Emission Tomography and Bioprosthetic Aortic Valve Thrombus. JACC Cardiovasc Imaging. 2022 Jan 11:S1936-878X(21)00845-7. doi: 10.1016/j.jcmg.2021.11.015. https://pubmed.ncbi.nlm.nih.gov/35033495/
    • Tzolos E et al. (2021). Categorising myocardial infarction with advanced cardiovascular imaging. 2021 Aug 7;398(10299):e9. doi: 10.1016/S0140-6736(21)01329-5. https://pubmed.ncbi.nlm.nih.gov/34364527/
    • Hugenberg V et al. (2021) GMP-Compliant Radiosynthesis of [18F]GP1, a Novel PET Tracer for the Detection of Thrombi. Pharmaceuticals 2021, 14(8), 739 Click here to access the pdf
    • Lee N et al. (2019) Radiation dosimetry of [18F]GP1 for imaging activated glycoprotein IIb/IIIa receptors with positron emission tomography in patients with acute thromboembolism. Nucl Med Biol. May-Jun 2019;72-73:45-48. https://pubmed.ncbi.nlm.nih.gov/31330411/
    • Chae SY et al. (2019) A phase 1, first-in-human study of 18F-GP1 positron emission tomography for imaging acute arterial thrombosis. EJNMMI Res. 2019 Jan 7;9(1):3 https://www.ncbi.nlm.nih.gov/pubmed/30617563
    • Kim C. et al. (2018) Glycoprotein IIb/IIIa receptor imaging with 18F-GP1 positron emission tomography for acute venous thromboembolism: an open-label, non-randomized, first-in-human phase 1 study. J Nucl Med. 2019 Feb;60(2):244-249. https://www.ncbi.nlm.nih.gov/pubmed/29959214
    • Lohrke J et al. (2017) 18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. J Nucl Med. 2017 Jul;58(7):1094-1099. Click here to access the pdf
Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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