A Pilot Study to Evaluate 18F Florbetapir Binding to Cardiac Amyloid in Patients Undergoing Chemotherapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Allergy to F-18 florbetapir
Arms & Interventions
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.
Intervention: F18 Florbetapir (amyvid) cardiac PET/CT imaging (Drug)
Outcomes
Primary Outcomes
Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
Time Frame: six months
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
Relative Change in Cardiac Uptake of 18F Florbetapir Prior to Chemotherapy and After Six Months of Chemotherapy.
Time Frame: six months
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
Secondary Outcomes
- six minute walk test(twelve months)
- Hematologic response(12 months)
- Cardiac response(12 months)
- Patient related outcomes(12 months)
- Six Minute Walk Test(twelve months)
- Hematologic Response(12 months)
- Cardiac Response(12 months)
- Patient Related Outcomes(12 months)
Investigators
Christopher Mueller
MD, Assistant Professor Department of Medicine.
Medical College of Wisconsin