drugset / Trial / NCT05374564
Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
NaSingle-groupOpen-labelDiagnostic
Summary
18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved 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) or other causes of cognitive decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis.
Timeline
- Start
- 2022-08-16
- Primary completion
- 2024-11-14
- Completion
- 2024-11-14
Publications
- Results Maurer MS, Bokhari S, Damy T, Dorbala S, Drachman BM, Fontana M, Grogan M, Kristen AV, Lousada I, Nativi-Nicolau J, Cristina Quarta C, Rapezzi C, Ruberg FL, Witteles R, Merlini G. Expert Consensus Recommendations for the Suspicion and Diagnosis of Transthyretin Cardiac Amyloidosis. Circ Heart Fail. 2019 Sep;12(9):e006075. doi: 10.1161/CIRCHEARTFAILURE.119.006075. Epub 2019 Sep 4.
- Results Gillmore JD, Damy T, Fontana M, Hutchinson M, Lachmann HJ, Martinez-Naharro A, Quarta CC, Rezk T, Whelan CJ, Gonzalez-Lopez E, Lane T, Gilbertson JA, Rowczenio D, Petrie A, Hawkins PN. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018 Aug 7;39(30):2799-2806. doi: 10.1093/eurheartj/ehx589.
- Results Leuzy A, Savitcheva I, Chiotis K, Lilja J, Andersen P, Bogdanovic N, Jelic V, Nordberg A. Clinical impact of [18F]flutemetamol PET among memory clinic patients with an unclear diagnosis. Eur J Nucl Med Mol Imaging. 2019 Jun;46(6):1276-1286. doi: 10.1007/s00259-019-04297-5. Epub 2019 Mar 26.
- Results Dietemann S, Nkoulou R. Amyloid PET imaging in cardiac amyloidosis: a pilot study using 18F-flutemetamol positron emission tomography. Ann Nucl Med. 2019 Aug;33(8):624-628. doi: 10.1007/s12149-019-01372-7. Epub 2019 May 28.
- Results Papathanasiou M, Kessler L, Carpinteiro A, Hagenacker T, Nensa F, Umutlu L, Forsting M, Brainman A, Kleinschnitz C, Antoch G, Duhrsen U, Schlosser TW, Herrmann K, Rassaf T, Luedike P, Rischpler C. 18F-flutemetamol positron emission tomography in cardiac amyloidosis. J Nucl Cardiol. 2022 Apr;29(2):779-789. doi: 10.1007/s12350-020-02363-2. Epub 2020 Oct 6.
- Results Mockelind S, Axelsson J, Pilebro B, Lindqvist P, Suhr OB, Sundstrom T. Quantification of cardiac amyloid with [18F]Flutemetamol in patients with V30M hereditary transthyretin amyloidosis. Amyloid. 2020 Sep;27(3):191-199. doi: 10.1080/13506129.2020.1760237. Epub 2020 May 13.
- Results Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
- Results Kazi DS, Bellows BK, Baron SJ, Shen C, Cohen DJ, Spertus JA, Yeh RW, Arnold SV, Sperry BW, Maurer MS, Shah SJ. Cost-Effectiveness of Tafamidis Therapy for Transthyretin Amyloid Cardiomyopathy. Circulation. 2020 Apr 14;141(15):1214-1224. doi: 10.1161/CIRCULATIONAHA.119.045093. Epub 2020 Feb 12.
- Results Masri A, Chen H, Wong C, Fischer KL, Karam C, Gellad WF, Heitner SB. Initial Experience Prescribing Commercial Tafamidis, the Most Expensive Cardiac Medication in History. JAMA Cardiol. 2020 Sep 1;5(9):1066-1067. doi: 10.1001/jamacardio.2020.1738.
- Results Gallegos C, Miller EJ. Advances in PET-Based Cardiac Amyloid Radiotracers. Curr Cardiol Rep. 2020 May 19;22(6):40. doi: 10.1007/s11886-020-01284-3.
- Results Ye Q, Wu J, Lu Y, Naganawa M, Gallezot JD, Ma T, Liu Y, Tanoue L, Detterbeck F, Blasberg J, Chen MK, Casey M, Carson RE, Liu C. Improved discrimination between benign and malignant LDCT screening-detected lung nodules with dynamic over static 18F-FDG PET as a function of injected dose. Phys Med Biol. 2018 Sep 6;63(17):175015. doi: 10.1088/1361-6560/aad97f.
- Results Tanskanen M, Peuralinna T, Polvikoski T, Notkola IL, Sulkava R, Hardy J, Singleton A, Kiuru-Enari S, Paetau A, Tienari PJ, Myllykangas L. Senile systemic amyloidosis affects 25% of the very aged and associates with genetic variation in alpha2-macroglobulin and tau: a population-based autopsy study. Ann Med. 2008;40(3):232-9. doi: 10.1080/07853890701842988.
- Results Gonzalez-Lopez E, Gallego-Delgado M, Guzzo-Merello G, de Haro-Del Moral FJ, Cobo-Marcos M, Robles C, Bornstein B, Salas C, Lara-Pezzi E, Alonso-Pulpon L, Garcia-Pavia P. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015 Oct 7;36(38):2585-94. doi: 10.1093/eurheartj/ehv338. Epub 2015 Jul 28.
- Results Donnelly JP, Hanna M, Sperry BW, Seitz WH Jr. Carpal Tunnel Syndrome: A Potential Early, Red-Flag Sign of Amyloidosis. J Hand Surg Am. 2019 Oct;44(10):868-876. doi: 10.1016/j.jhsa.2019.06.016. Epub 2019 Aug 7.
- Results Castano A, Narotsky DL, Hamid N, Khalique OK, Morgenstern R, DeLuca A, Rubin J, Chiuzan C, Nazif T, Vahl T, George I, Kodali S, Leon MB, Hahn R, Bokhari S, Maurer MS. Unveiling transthyretin cardiac amyloidosis and its predictors among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Eur Heart J. 2017 Oct 7;38(38):2879-2887. doi: 10.1093/eurheartj/ehx350.
- Results Buxbaum J, Jacobson DR, Tagoe C, Alexander A, Kitzman DW, Greenberg B, Thaneemit-Chen S, Lavori P. Transthyretin V122I in African Americans with congestive heart failure. J Am Coll Cardiol. 2006 Apr 18;47(8):1724-5. doi: 10.1016/j.jacc.2006.01.042. Epub 2006 Mar 29. No abstract available.
- Results Papoutsidakis N, Miller EJ, Rodonski A, Jacoby D. Time Course of Common Clinical Manifestations in Patients with Transthyretin Cardiac Amyloidosis: Delay From Symptom Onset to Diagnosis. J Card Fail. 2018 Feb;24(2):131-133. doi: 10.1016/j.cardfail.2017.12.005. Epub 2018 Jan 3. No abstract available.
- Results Jacobson DR, Alexander AA, Tagoe C, Garvey WT, Williams SM, Tishkoff S, Modiano D, Sirima SB, Kalidi I, Toure A, Buxbaum JN. The prevalence and distribution of the amyloidogenic transthyretin (TTR) V122I allele in Africa. Mol Genet Genomic Med. 2016 Jul 14;4(5):548-56. doi: 10.1002/mgg3.231. eCollection 2016 Sep.
- Results Damy T, Kristen AV, Suhr OB, Maurer MS, Plante-Bordeneuve V, Yu CR, Ong ML, Coelho T, Rapezzi C; THAOS Investigators. Transthyretin cardiac amyloidosis in continental Western Europe: an insight through the Transthyretin Amyloidosis Outcomes Survey (THAOS). Eur Heart J. 2022 Feb 3;43(5):391-400. doi: 10.1093/eurheartj/ehz173.
- Results Quarta CC, Buxbaum JN, Shah AM, Falk RH, Claggett B, Kitzman DW, Mosley TH, Butler KR, Boerwinkle E, Solomon SD. The amyloidogenic V122I transthyretin variant in elderly black Americans. N Engl J Med. 2015 Jan 1;372(1):21-9. doi: 10.1056/NEJMoa1404852.
- Results Feher A, Srivastava A, Quail MA, Boutagy NE, Khanna P, Wilson L, Miller EJ, Liu YH, Lee F, Sinusas AJ. Serial Assessment of Coronary Flow Reserve by Rubidium-82 Positron Emission Tomography Predicts Mortality in Heart Transplant Recipients. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 1):109-120. doi: 10.1016/j.jcmg.2018.08.025. Epub 2018 Oct 17.
- Results Heurling K, Buckley C, Van Laere K, Vandenberghe R, Lubberink M. Parametric imaging and quantitative analysis of the PET amyloid ligand [(18)F]flutemetamol. Neuroimage. 2015 Nov 1;121:184-92. doi: 10.1016/j.neuroimage.2015.07.037. Epub 2015 Jul 22.
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- Results Delforge J, Syrota A, Mazoyer BM. Identifiability analysis and parameter identification of an in vivo ligand-receptor model from PET data. IEEE Trans Biomed Eng. 1990 Jul;37(7):653-61. doi: 10.1109/10.55673.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flutemetamol | Diagnostic / imaging agent | — | — |