Clinical trial NCT03333551: Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy
Official title: A Pilot Study to Evaluate 18F Florbetapir Binding to Cardiac Amyloid in Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cardiac Amyloidosis
Keywords: AL Cardiac Amyloidosis
18F-Florbetapir (Amyvid)
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: each participant will be subject to the intervention which is PET/CT imaging (Positron emission tomography-computed tomography) with florbetapir F-18
Primary purpose: DIAGNOSTIC

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.

Detailed description: Current research involving \[18F\]-florbetapir in relationship to cardiac amyloid has taken advantage of the ability of the radiopharmaceutical to bind specifically to amyloid fibrils. It has previously been established that the degree of radiotracer uptake correlates with the density of Beta-amyloid plaque. The ability to quantify this uptake makes \[18F\]-florbetapir imaging a potential tool to evaluate cardiac response in patients undergoing therapy for AL amyloidosis. It would provide a much-needed tool to monitor cardiac response to chemotherapy to potentially adjust chemotherapy if response was not adequate. It could also provide a tool by which investigators would be able to evaluate new therapies designed to decrease the burden of formed amyloid fibrils within the heart.

Eligibility criteria: Inclusion Criteria:

1. Patients aged \> 18 years are eligible.
2. Patient must provide informed consent to participate in the study protocol.
3. 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).
4. Planned plasma cell-directed chemotherapy.
5. A negative pregnancy test will be required for all women of child bearing potential, breast feeding is not permitted.
6. Patients must be able to undergo PET-CT imaging
7. Patients must be able to complete 6-minute walk test

Exclusion Criteria:

1. Severe claustrophobia
2. Pregnancy
3. Allergy to F-18 florbetapir

Primary outcomes:
measure: Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
timeFrame: six months
Secondary outcomes:
measure: six minute walk test
timeFrame: twelve months
measure: Hematologic response
timeFrame: 12 months
measure: Cardiac response
timeFrame: 12 months
measure: Patient related outcomes
timeFrame: 12 months
measure: Patient related outcomes
timeFrame: 12 months
measure: Patient related outcomes
timeFrame: 12 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Chris Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.