Trial Outcomes & Findings for Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy (NCT NCT03333551)
NCT ID: NCT03333551
Last Updated: 2026-07-16
Results Overview
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
TERMINATED
PHASE4
4 participants
six months
2026-07-16
Participant Flow
4 patients consented for the study. 1 withdrew prior to any study activity. 3 died prior to completion of the study.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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4
|
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Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
|
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Overall Study
Death
|
3
|
Baseline Characteristics
Complete baseline data was not collected for one participant because they withdrew prior to any study activities.
Baseline characteristics by cohort
| Measure |
Patients With AL Cardiac Amyloid
n=4 Participants
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.
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
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Six-Minute Walk
|
34.7 yards
STANDARD_DEVIATION 5.7 • n=3 Participants • Complete baseline data was not collected for one participant because they withdrew prior to any study activities.
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PRIMARY outcome
Timeframe: six monthsPopulation: No analyzable data were available at six months due to participant withdrawal (n=1) and death (n=3) prior to repeat imaging.
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: twelve monthsPopulation: None of the patients enrolled were able to complete the follow up 6 minute walk tests at 6 and 12 months so there is no data to compare.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: None of the patients enrolled were able to complete the labs for hematologic response and the follow up labs at 6 and 12 months so there is no data to compare.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: None of the patients enrolled were able to complete the labs for cardiac response and the follow up labs at 6 and 12 months so there is no data to compare.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: None of the patients enrolled were able to complete the patient related outcomes surveys and the follow up patient related outcomes survey at 6 and 12 months so there is no data to compare.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: None of the patients enrolled in the study were able to complete the initial patient related outcomes survey as well as the follow up patient related outcomes survey at 6 and 12 months so there is no data to compare.
Correlation of cardiac 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: None of the patients enrolled in the study were able to complete the initial patient related outcomes survey as well as the follow up patient related outcomes survey at 6 and 12 months so there is no data to compare.
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 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.
Outcome measures
Outcome data not reported
Adverse Events
Patients With AL Cardiac Amyloid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place