AL Amyloidosis Clinical Trial

Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

AL Amyloidosis

Phase:

Phase 4

Estimated Enrollment:

3

Study ID:

NCT03333551

Recruitment Status:

Terminated

Sponsor:

Medical College of Wisconsin

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There is 1 Location for this study

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Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

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Study is for people with:

AL Amyloidosis

Phase:

Phase 4

Estimated Enrollment:

3

Study ID:

NCT03333551

Recruitment Status:

Terminated

Sponsor:


Medical College of Wisconsin

How clear is this clinincal trial information?

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