Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy

NCT03333551 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 29197
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study designed to assess for relative change in cardiac 18F Florbetapir uptake in patients with AL cardiac amyloidosis after appropriate chemotherapy.

Conditions

Cardiac Amyloidosis

Keywords

AL Cardiac Amyloidosis; 18F-Florbetapir (Amyvid)

Outcome Measures

Primary Outcomes (1)

• Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.

  Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.

  six months

Secondary Outcomes (6)

• six minute walk test

  twelve months

• Hematologic response

  12 months

• Cardiac response

  12 months

• Patient related outcomes

  12 months

• Patient related outcomes

  12 months

Study Arms (1)

Patients with AL cardiac amyloid

EXPERIMENTAL

Patients enrolled will be patients \> 18 years of age with a clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis) with plans to undergo plasma cell directed chemotherapy.

Drug: F18 Florbetapir (amyvid) cardiac PET/CT imaging

Interventions

F18 Florbetapir (amyvid) cardiac PET/CT imaging DRUG

Patients with cardiac amyloidosis (AL) undergoing planned plasma cell directed chemotherapy will have F-18 florbetapir (amyvid) cardiac PET/CT imaging prior to starting chemotherapy and six months after onset of treatment.

Also known as: Amyvid

Patients with AL cardiac amyloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \> 18 years are eligible.
• Patient must provide informed consent to participate in the study protocol.
• All patients must have clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or cardiac MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis).
• Planned plasma cell-directed chemotherapy.
• A negative pregnancy test will be required for all women of child bearing potential, breast feeding is not permitted.
• Patients must be able to undergo PET-CT imaging
• Patients must be able to complete 6-minute walk test

You may not qualify if:

• Severe claustrophobia
• Pregnancy
• Allergy to F-18 florbetapir

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (7)

• 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.

  PMID: 23337445 BACKGROUND

• 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.

  PMID: 24841414 BACKGROUND

• Osborne DR, Acuff SN, Stuckey A, Wall JS. A Routine PET/CT Protocol with Streamlined Calculations for Assessing Cardiac Amyloidosis Using (18)F-Florbetapir. Front Cardiovasc Med. 2015 May 8;2:23. doi: 10.3389/fcvm.2015.00023. eCollection 2015.

  PMID: 26664895 BACKGROUND

• Lister-James J, Pontecorvo MJ, Clark C, Joshi AD, Mintun MA, Zhang W, Lim N, Zhuang Z, Golding G, Choi SR, Benedum TE, Kennedy P, Hefti F, Carpenter AP, Kung HF, Skovronsky DM. Florbetapir f-18: a histopathologically validated Beta-amyloid positron emission tomography imaging agent. Semin Nucl Med. 2011 Jul;41(4):300-4. doi: 10.1053/j.semnuclmed.2011.03.001.

  PMID: 21624563 BACKGROUND

• 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.

  PMID: 26259579 BACKGROUND

• 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.

  PMID: 21368874 BACKGROUND

• 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.

  PMID: 12904524 BACKGROUND

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Chris Mueller, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor Department of Medicine.

Model Details: each participant will be subject to the intervention which is PET/CT imaging (Positron emission tomography-computed tomography) with florbetapir F-18

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: November 7, 2017
• Study Start: October 1, 2020
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

US (1)