Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy

Phase 4

Terminated

• Conditions: Cardiac Amyloidosis
• Interventions: Drug: F18 Florbetapir (amyvid) cardiac PET/CT imaging

• Registration Number: NCT03333551
• Lead Sponsor: Medical College of Wisconsin

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 Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-07
• Study Start: 2020-10-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with AL cardiac amyloid	F18 Florbetapir (amyvid) cardiac PET/CT imaging	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.

Primary Outcome Measures

Name	Time	Method
Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.	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 Outcome Measures

Name	Time	Method
Patient related outcomes	12 months	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
six minute walk test	twelve months	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.
Hematologic response	12 months	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.
Cardiac response	12 months	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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States