Study Summary
This trial will test if a chemotherapy regimen can reduce the amount of amyloid protein in the heart of patients with AL amyloidosis.
Eligible Conditions
- Cardiac Amyloidosis
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 12 months
12 months
Cardiac response
Hematologic response
Patient related outcomes
six months
Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
twelve months
six minute walk test
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Patients with AL cardiac amyloid
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: F18 Florbetapir (amyvid) cardiac PET/CT imaging · No Placebo Group · Phase 4
Patients with AL cardiac amyloid
Drug
Experimental Group · 1 Intervention: F18 Florbetapir (amyvid) cardiac PET/CT imaging · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
566 Previous Clinical Trials
1,154,158 Total Patients Enrolled
Chris Mueller, MDPrincipal InvestigatorMedical College of Wisconsin
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a woman of child bearing potential.
References
- Sikkink, L A, and M Ramirez-Alvarado. 2010. “Cytotoxicity of Amyloidogenic Immunoglobulin Light Chains in Cell Culture”. Cell Death & Disease. Springer Science and Business Media LLC. doi:10.1038/cddis.2010.75.
- Esplin, Brandt L., and Morie A. Gertz. 2013. “Current Trends in Diagnosis and Management of Cardiac Amyloidosis”. Current Problems in Cardiology. Elsevier BV. doi:10.1016/j.cpcardiol.2012.11.002.
- Osborne, Dustin R., Shelley N. Acuff, Alan Stuckey, and Jonathan S. Wall. 2015. “A Routine PET/CT Protocol with Streamlined Calculations for Assessing Cardiac Amyloidosis Using 18f-florbetapir”. Frontiers in Cardiovascular Medicine. Frontiers Media SA. doi:10.3389/fcvm.2015.00023.
- Merlini, Giampaolo, and Vittorio Bellotti. 2003. “Molecular Mechanisms of Amyloidosis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmra023144.
- Park, Mi-Ae, Robert F. Padera, Anthony Belanger, Shipra Dubey, David H. Hwang, Vikas Veeranna, Rodney H. Falk, Marcelo F. Di Carli, and Sharmila Dorbala. 2015. “18 F-florbetapir Binds Specifically to Myocardial Light Chain and Transthyretin Amyloid Deposits”. Circulation: Cardiovascular Imaging. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circimaging.114.002954.
- Dorbala, Sharmila, Divya Vangala, James Semer, Christopher Strader, John R. Bruyere Jr, Marcelo F. Di Carli, Stephen C. Moore, and Rodney H Falk. 2014. “Imaging Cardiac Amyloidosis: A Pilot Study Using 18f-florbetapir Positron Emission Tomography”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-014-2787-6.
- Lister-James, John, Michael J. Pontecorvo, Chris Clark, Abhinay D. Joshi, Mark A. Mintun, Wei Zhang, Nathaniel Lim, et al.. 2011. “Florbetapir F-18: A Histopathologically Validated Beta-amyloid Positron Emission Tomography Imaging Agent”. Seminars in Nuclear Medicine. Elsevier BV. doi:10.1053/j.semnuclmed.2011.03.001.
- Dorbala, Sharmila, Divya Vangala, James Semer, Christopher Strader, John R. Bruyere Jr, Marcelo F. Di Carli, Stephen C. Moore, and Rodney H Falk. 2014. “Imaging Cardiac Amyloidosis: A Pilot Study Using 18f-florbetapir Positron Emission Tomography”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-014-2787-6.
- Dorbala S, Vangala D, Semer J, Strader C, Bruyere JR Jr, Di Carli MF, Moore SC, Falk RH. Imaging cardiac amyloidosis: a pilot study using (1)(8)F-florbetapir positron emission tomography. Eur J Nucl Med Mol Imaging. 2014 Sep;41(9):1652-62. doi: 10.1007/s00259-014-2787-6. Epub 2014 May 20.
- Esplin BL, Gertz MA. Current trends in diagnosis and management of cardiac amyloidosis. Curr Probl Cardiol. 2013 Feb;38(2):53-96. doi: 10.1016/j.cpcardiol.2012.11.002.
- Merlini G, Bellotti V. Molecular mechanisms of amyloidosis. N Engl J Med. 2003 Aug 7;349(6):583-96. doi: 10.1056/NEJMra023144. No abstract available.
- Sikkink LA, Ramirez-Alvarado M. Cytotoxicity of amyloidogenic immunoglobulin light chains in cell culture. Cell Death Dis. 2010 Nov 11;1(11):e98. doi: 10.1038/cddis.2010.75.
- Park MA, Padera RF, Belanger A, Dubey S, Hwang DH, Veeranna V, Falk RH, Di Carli MF, Dorbala S. 18F-Florbetapir Binds Specifically to Myocardial Light Chain and Transthyretin Amyloid Deposits: Autoradiography Study. Circ Cardiovasc Imaging. 2015 Aug;8(8):10.1161/CIRCIMAGING.114.002954 e002954. doi: 10.1161/CIRCIMAGING.114.002954.
- Christopher Mueller 2020. "Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03333551.
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