Cardiac Amyloidosis
Conditions
Keywords
AL Cardiac Amyloidosis, 18F-Florbetapir (Amyvid)
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.
Interventions
DRUGF18 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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
each participant will be subject to the intervention which is PET/CT imaging (Positron emission tomography-computed tomography) with florbetapir F-18
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Patient Related Outcomes | 12 months | Correlation of hematologic response to results of patient related outcomes survey completed at 0, 6, and 12 months. Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChris Mueller, MD
Medical College of Wisconsin
Participant flow
Pre-assignment details
4 patients consented for the study. 1 withdrew prior to any study activity. 3 died prior to completion of the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
| Six-Minute Walk | 34.7 yards STANDARD_DEVIATION 5.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
None listed