Vizamyl

Manufactured by GE Healthcare

Sourced in United Kingdom

Vizamyl is a radiopharmaceutical imaging agent developed by GE Healthcare for use in Positron Emission Tomography (PET) imaging. It is designed to detect beta-amyloid plaques in the brain, which are associated with Alzheimer's disease.

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Lab products found in correlation

Biograph 40 truev hd, by Siemens (2 mentions) Amyvid, by Eli Lilly (2 mentions) Intellispace portal, by Philips (1 mentions) Discovery st scanner, by GE Healthcare (1 mentions)

12 protocols using vizamyl

Validation of [18F]flutemetamol PET Imaging

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Image acquisition started ∼90 min after the administration of [¹⁸F]flutemetamol injection (VIZAMYL™; GE Healthcare, Little Chalfont, UK) and comprised six 5 min frames after a 185 MBq dose (n=208) or five 2 min frames after a 370 MBq dose (n=68). To ensure similar image signals, only the first four imaging frames (20 min) were used from 185 MBq scans to approximate the image signal of a 10 min, 370 MBq scan.
Depending on the contributing study, image selection was complete (where histopathological SoT was available) or from a random sample (in larger studies without a SoT). No images selected for the blinded image evaluation portion of the validation study had been used previously in the reader training programme. To assess intrareader reproducibility (IRR), 29 (10.5%) of the 276 images were selected at random and duplicated, and the originals and duplicates were included in the image set, for a total of 305 images.

Buckley C.J., Sherwin P.F., Smith A.P., Wolber J., Weick S.M, & Brooks D.J. (2016). Validation of an electronic image reader training programme for interpretation of [18F]flutemetamol β-amyloid PET brain images. Nuclear Medicine Communications, 38(3), 234-241.

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FMM PET/CT Imaging Protocol

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A gross activity of 206.7 ± 12.7 MBq of FMM (Vizamyl; GE Healthcare) was measured 3.9 ± 3.0 min before dose administration. A noncontrast low-dose CT scan was performed for attenuation correction in the PET/CT scanner (Biograph 40 TrueV HD; Siemens). A PET list-mode acquisition was performed starting at the time of FMM administration. Data were acquired for 8 min and rebinned to dynamic datasets of 4 × 2 min without attenuation correction for motion checking only. The early-phase images were initially iteratively reconstructed to a 168 × 168 matrix, with three iterations, 21 subsets, zoom 2 and Gaussian filter 2 mm using attenuation, scatter and point spread function correction. After an uptake time of 90.6 ± 5.1 min, late-phase data were acquired for 20 min and reconstructed to a 168 × 168 matrix, with the other parameters as given above including rebinning into dynamic sequences for motion checking. After initial experience with the first 25 investigations, we shortened the late-phase acquisition time from 20 min to 10 min due to frequent patient motion in the late phase of the acquisition. We also changed the reconstruction matrix from 168 × 168 to 128 × 128 (with the other parameters as given above) to achieve a low level of noise without apparent loss of diagnostic image quality.

Belohlavek O., Jaruskova M., Skopalova M., Szarazova G, & Simonova K. (2018). Improved beta-amyloid PET reproducibility using two-phase acquisition and grey matter delineation. European Journal of Nuclear Medicine and Molecular Imaging, 46(2), 297-303.

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Harmonized PET Amyloid Imaging Data

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PET amyloid imaging was available for 643 participants of the analytical sample, using either ¹⁸F-florbetapir (Amyvid, Eli Lilly) (n = 437) or ¹⁸F-flutemetamol (Vizamyl, GE Healthcare) (n = 206) radioligands. Mean brain amyloid SUVR was computed, harmonized across the radioligands,^{34 (link)} and used for the current study.

Frison E., Proust-Lima C., Mangin J.F., Habert M.O., Bombois S., Ousset P.J., Pasquier F., Hanon O., Paquet C., Gabelle A., Ceccaldi M., Annweiler C., Krolak-Salmon P., Béjot Y., Belin C., Wallon D., Sauvee M., Beaufils E., Bourdel-Marchasson I., Jalenques I., Chupin M., Chêne G, & Dufouil C. (2021). Diabetes Mellitus and Cognition: Pathway Analysis in the MEMENTO Cohort. Neurology, 97(8), e836-e848.

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Amyloid PET Tracers and Imaging in Alzheimer's Disease

Cited 2 times

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In the PARIS discovery cohort, 3 amyloid PET tracers were used: (¹⁸F)florbetapir (Amyvid; Lilly Diagnostics), (¹⁸F)florbetaben (Neuraceq; Life Molecular Imaging) or (¹⁸F)flutemetamol (Vizamyl; GE Healthcare). While in the IDEAS study, amyloid PET scans were interpreted visually by local radiologists and nuclear medicine physicians, for PARIS, amyloid PET images were obtained and processed by the American College of Radiology and analyzed by 2 board-certified radiologists with amyloid PET tracer–specific training. In the MissionAD data set used for this study, 2 amyloid PET tracers were used: (¹⁸F)florbetapir and (¹⁸F)florbetaben, and amyloid PET images were processed by Bioclinica. Image analyses, including standardized uptake value ratio to Centiloid conversion, are described in the eMethods in the Supplement. For purposes of determining eligibility for MissionAD, PET visual read was used. Based on published evidence,^{21 (link),22 (link)} we a priori defined amyloid positivity for our analyses as Centiloid value greater than 25, which is a more sensitive threshold for brain amyloid plaques than visual read.

Hu Y., Kirmess K.M., Meyer M.R., Rabinovici G.D., Gatsonis C., Siegel B.A., Whitmer R.A., Apgar C., Hanna L., Kanekiyo M., Kaplow J., Koyama A., Verbel D., Holubasch M.S., Knapik S.S., Connor J., Contois J.H., Jackson E.N., Harpstrite S.E., Bateman R.J., Holtzman D.M., Verghese P.B., Fogelman I., Braunstein J.B., Yarasheski K.E, & West T. (2022). Assessment of a Plasma Amyloid Probability Score to Estimate Amyloid Positron Emission Tomography Findings Among Adults With Cognitive Impairment. JAMA Network Open, 5(4), e228392.

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Amyloid-PET Imaging in Elderly Patients

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Eighty patients underwent an amyloid-PET scan with [¹⁸F] flutemetamol (n = 28) or [¹¹C] Pittsburgh compound-B (PiB, n = 52). Amyloid-PET imaging was performed on one of two possible PET scanner systems (Siemens Biograph 64 True Point, Erlangen, Germany or GE Advances PET, GE Healthcare Institute, Waukesha, Wisconsin, USA). All studies were performed under strictly controlled conditions. In short, either ~400 MBq of [11C] PiB (in-house production according to previously published recommendations; Philippe et al., 2011 (link)) or 185 MBq of [18F] flutemetamol (Vizamyl^®, GE Healthcare) were injected intravenously into a peripheral vein with starting image acquisition 40 min p.i. for [11C] PiB and 90 min p.i. for Vizamyl^®, where the tracer accumulation in the brain is reaching the maximum. Subsequently, the image acquisition was performed for about 20 min following a computed tomography (CT) acquisition for attenuation correction using Siemens Biograph 64 True Point.
Scans were rated visually as positive or negative for the presence of amyloid pathology in the cortex by an experienced nuclear medicine physician according to the guidelines of the tracer manufacturers.

Parvizi T., König T., Wurm R., Silvaieh S., Altmann P., Klotz S., Rommer P.S., Furtner J., Regelsberger G., Lehrner J., Traub-Weidinger T., Gelpi E, & Stögmann E. (2022). Real-world applicability of glial fibrillary acidic protein and neurofilament light chain in Alzheimer’s disease. Frontiers in Aging Neuroscience, 14, 887498.

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Amyloid-PET Disclosure Guidelines for SCD+

Cited 1 time

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In AMYPAD-DPMS, amyloid-PET scans were acquired with either [18F]flutemetamol (Vizamyl, GE Healthcare, Amersham United Kingdom) or [18F]florbetaben (Neuraceq, Life Molecular Imaging, Berlin, Germany) as amyloid-PET tracers, and visually assessed by trained local nuclear medicine physicians using reading methods approved by the US Food and Drug Administration and the European Medicines Agency for the 2 tracers. The AMYPAD consortium recommended the disclosure of the amyloid-PET result in participants with SCD+. Before the beginning of participants’ recruitment, we developed ad hoc nonprescriptive disclosure guidelines (eTable 1 in Supplement 1) adapted from those used in the A4 trial^{29 (link)} and a brochure template (eTable 2 in Supplement 1) to support managing physicians in the disclosure process. Nevertheless, managing physicians may or may not have followed the disclosure guidelines, and delivered, all or in part, information outlined in the disclosure brochure template. Moreover, we recorded whether it was communicated that SCD+ is a risk condition for the future development of cognitive impairment or dementia, whether the amyloid-PET result was disclosed in person (face-to-face) or over the phone, and the disclosure duration by using an ad hoc questionnaire.

Caprioglio C., Ribaldi F., Visser L.N., Minguillon C., Collij L.E., Grau-Rivera O., Zeyen P., Molinuevo J.L., Gispert J.D., Garibotto V., Moro C., Walker Z., Edison P., Demonet J.F., Barkhof F., Scheltens P., Alves I.L., Gismondi R., Farrar G., Stephens A.W., Jessen F., Frisoni G.B, & Altomare D. (2023). Analysis of Psychological Symptoms Following Disclosure of Amyloid–Positron Emission Tomography Imaging Results to Adults With Subjective Cognitive Decline. JAMA Network Open, 6(1), e2250921.

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Flutemetamol (18F) PET Imaging Protocol

Cited 1 time

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Patients underwent head computed tomography or magnetic resonance scanning either up to 6 months before the PET scan or during PET imaging. The administered activity of Flutemetamol (¹⁸F) Injection (Vizamyl, GE Healthcare, Marlborough, MA, USA) was 185 to 370 MBq. PET acquisition was carried out for 10 to 20 min (depending on the injected activity) in 2-minute frames starting 90 minutes after injection. Images were corrected for attenuation. Axial slices (128 × 128) were generated by iterative reconstruction and smoothed with a Gaussian postreconstruction filter when required [9] (link), [23] (link).

Salloway S., Gamez J.E., Singh U., Sadowsky C.H., Villena T., Sabbagh M.N., Beach T.G., Duara R., Fleisher A.S., Frey K.A., Walker Z., Hunjan A., Escovar Y.M., Agronin M.E., Ross J., Bozoki A., Akinola M., Shi J., Vandenberghe R., Ikonomovic M.D., Sherwin P.F., Farrar G., Smith A.P., Buckley C.J., Thal D.R., Zanette M, & Curtis C. (2017). Performance of [18F]flutemetamol amyloid imaging against the neuritic plaque component of CERAD and the current (2012) NIA-AA recommendations for the neuropathologic diagnosis of Alzheimer's disease. Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring, 9, 25-34.

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Amyloid PET Imaging in Neurodegenerative Disorders

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Amyloid-PET scan was carried out in all participants. [¹⁸F]-florbetapir (Amyvid, Eli Lilly & Co. and Avid Radiopharmaceuticals Inc.), [¹⁸F]-florbetaben (Neuraceq, Pyramidal Imaging Limited), and [¹⁸F]-flutemetamol (Vizamyl, GE Healthcare) PET scans were performed at the 12 de Octubre University Hospital, Pablo de Olavide University and the National Centre for Cardiovascular Research (CNIC), as previously described 31 (link), 32 (link), 33 (link). Images were generated 90–110 min after [¹⁸F]‐florbetaben intravenous injection (mean dose, 300 MBq) or 90 min after [¹⁸F]-flutemetamol intravenous injection (mean dose, 185 MBq; 20 min acquisition) or [¹⁸F]-florbetapir intravenous injection (mean dose, 370 MBq; 20 min acquisition). Images were analysed with the Syngo PET 6•7•2 (Siemens Healthcare) software and IntelliSpace Portal (Philips Healthcare) software. PET scans were analysed using standardised criteria [34] (link).

González-Sánchez M., Bartolome F., Antequera D., Puertas-Martín V., González P., Gómez-Grande A., Llamas-Velasco S., Herrero-San Martín A., Pérez-Martínez D., Villarejo-Galende A., Atienza M., Palomar-Bonet M., Cantero J.L., Perry G., Orive G., Ibañez B., Bueno H., Fuster V, & Carro E. (2020). Decreased salivary lactoferrin levels are specific to Alzheimer's disease. EBioMedicine, 57, 102834.

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Centralized Quantitative Amyloid PET Analyses

Cited 3 times

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Amyloid PET image analyses of PARIS Discovery and MissionAD have been described elsewhere.
⁶ (link) Briefly, in the PARIS Discovery cohort, three amyloid PET tracers were used: [¹⁸F]florbetapir (Amyvid; Lilly Diagnostics), [¹⁸F]florbetaben (Neuraceq; Life Molecular Imaging), or [¹⁸F]flutemetamol (Vizamyl; GE Healthcare). In the IDEAS study, amyloid PET scans were interpreted visually by local radiologists and nuclear medicine physicians. However, for the PARIS study, these amyloid PET images were obtained and processed centrally by the American College of Radiology by two board‐certified radiologists with amyloid PET tracer‐specific training. Images were quantitatively assessed by standardized uptake value ratio (SUVR) and Centiloid (CL). In the MissionAD data set analyzed for this study, two amyloid PET tracers were used, [¹⁸F]florbetapir and [¹⁸F]florbetaben, and amyloid PET images were processed centrally by Bioclinica. Image analyses, including SUVR to CL conversion, are described in Hu et al.
⁶ (link) For the purposes of determining eligibility for MissionAD, PET visual read was used. Based on published evidence, we defined a priori amyloid positivity for our analyses as a CL value greater than 25, which is a more sensitive threshold for brain amyloid plaques than visual read.
¹⁵ (link),
¹⁶ (link)

Meyer M.R., Kirmess K.M., Eastwood S., Wente‐Roth T.L., Irvin F., Holubasch M.S., Venkatesh V., Fogelman I., Monane M., Hanna L., Rabinovici G.D., Siegel B.A., Whitmer R.A., Apgar C., Bateman R.J., Holtzman D.M., Irizarry M., Verbel D., Sachdev P., Ito S., Contois J., Yarasheski K.E., Braunstein J.B., Verghese P.B, & West T. (2024). Clinical validation of the PrecivityAD2 blood test: A mass spectrometry‐based test with algorithm combining %p‐tau217 and Aβ42/40 ratio to identify presence of brain amyloid. Alzheimer's & Dementia, 20(5), 3179-3192.

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Flutemetamol (18F) PET Imaging for Alzheimer's Detection

Cited 1 time

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The PET images were acquired using a Biograph 40 TrueV HD PET/CT scanner (Siemens Healthineers AG, Erlangen, Germany) in the Department of Nuclear Medicine and PET Centre, Na Homolce Hospital. The participants received a single intravenous dose of flutemetamol (18F; Vizamyl, GE Healthcare, Chicago, IL). Non-contrast low-dose CT brain images were acquired for attenuation correction prior to the PET scans. A PET list-mode acquisition was performed in two phases: early (perfusion) and late (β-amyloid). The early-phase images were acquired at the time of flutemetamol (18F) administration for 8 min and rebinned into dynamic datasets of 2 × 4 min for motion checking. The late-phase images were acquired 90 min after flutemetamol (18F) administration for a total of 10 min (2 × 5 min). Flutemetamol (18F) PET images were visually read (as positive or negative) by a certified nuclear medicine specialist using the GM-EDGE method [60 (link)].

Matuskova V., Veverova K., Jester D.J., Matoska V., Ismail Z., Sheardova K., Horakova H., Cerman J., Laczó J., Andel R., Hort J, & Vyhnalek M. (2024). Mild behavioral impairment in early Alzheimer’s disease and its association with APOE and BDNF risk genetic polymorphisms. Alzheimer's Research & Therapy, 16, 21.

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