- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03333551
Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy
May 8, 2023 updated by: Christopher Mueller, Medical College of Wisconsin
A Pilot Study to Evaluate 18F Florbetapir Binding to Cardiac Amyloid in Patients Undergoing Chemotherapy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe claustrophobia
- Pregnancy
- Allergy to F-18 florbetapir
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with AL cardiac amyloid
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
Time Frame: six months
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Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
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six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
six minute walk test
Time Frame: twelve months
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Change in Distance covered on six minute walk test at onset of chemotherapy will be compared to distance covered after six months of chemotherapy Distance at onset vs six months will be correlated with changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months.
Overall change in distance walked during 6 minute walk prior to starting chemotherapy and after 12 months of chemotherapy will be compared to any changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months.
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twelve months
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Hematologic response
Time Frame: 12 months
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correlation of hematologic response to treatment at 6 months and 18F florbetapir cardiac uptake changes between 0 and 6 months.
Hematologic response after 12 months will also be compared to any changes in 18F florbetapir cardiac uptake between 0 and 6 months.
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12 months
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Cardiac response
Time Frame: 12 months
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Cardiac response as defined by changes in NT proBNP (N Terminal proBNP) levels and cardiac Troponin T levels will be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months.
Changes in Cardiac troponin T and NT pro BNP levels after 12 months will also be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months.
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12 months
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Patient related outcomes
Time Frame: 12 months
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Correlation of hematologic response to results of patient related outcomes survey completed at 0, 6, and 12 months
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12 months
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Patient related outcomes
Time Frame: 12 months
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Correlation of cardiac response to results of patient related outcomes survey completed at 0, 6, and 12 months
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12 months
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Patient related outcomes
Time Frame: 12 months
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Correlation changes in 18F florbetapir cardiac uptake between 0 and 6 months to results of patient related outcomes survey completed at 0, 6, and 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chris Mueller, MD, Medical College of Wisconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
May 8, 2023
Study Completion (Actual)
May 8, 2023
Study Registration Dates
First Submitted
October 13, 2017
First Submitted That Met QC Criteria
November 2, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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