Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-05-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiac Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

F18 Florbetapir (amyvid) cardiac PET/CT imaging

Intervention Type 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.

Interventions

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F18 Florbetapir (amyvid) cardiac PET/CT imaging

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.

Intervention Type DRUG

Other Intervention Names

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Amyvid

Eligibility Criteria

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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