This trial studies how well molecular imaging using [18F]NOS or florbetaben PET/CT scan work in diagnosing a type of heart disorder called amyloidosis. [18F]NOS is an experimental radioactive drug used in PET/CT imaging to measure inflammation in various organs in the body. Florbetaben is a radioactive drug used for PET/CT imaging of amyloid plaques in the body. This trial is being done to determine if there is a difference between the two different types of PET/CT scans in the way they measure response to treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04105634.
PRIMARY OBJECTIVES:
I. Measure uptake of fluorine F 18 NOS ([18F]NOS) and florbetaben in patients with AL before and ~4 months (2 +/- weeks) after starting standard therapy and describe the distributions of uptake values at each time point.
II. Compute post-/pre-treatment fold change in [18F]NOS and florbetaben uptake and describe its distribution.
SECONDARY OBJECTIVES:
I. Describe fold changes in [18F]NOS uptake in patients who have a complete response or very good partial response vs patients who have a partial or no response to therapy at ~4 months.
II. Describe fold changes in florbetaben uptake in patients who have a complete response or very good partial response vs patients who have a partial or no response to therapy at ~4 months.
III. Describe fold changes in [18F]NOS uptake in patients who have an N-terminal fragment of the pro-brain natriuretic peptide (NT-proBNP) response at ~4 months vs patients who have no response or progression.
IV. Describe fold changes in florbetaben uptake in patients who have an NT-proBNP response at ~4 months vs patients who have no response or progression.
EXPLORATORY OBJECTIVE:
I. Compare baseline and 4-month post-therapy uptake values within patients, for each imaging cohort.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive fluorine F 18 NOS intravenously (IV) and undergo positron emission tomography (PET)/computed tomography (CT) scan over 60 minutes before treatment and 3-6 months after treatment.
GROUP II: Patients receive florbetaben (18F) IV and undergo PET/CT scan over 60 minutes before treatment and 3-6 months after treatment.
After completion of study, patients are followed up 1 day after scan.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorPaco Bravo