Primary Amyloidosis
Conditions
Keywords
Radioimmunoimaging, AL Amyloidosis, PET/CT
Brief summary
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.
Detailed description
To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 to 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.
Interventions
Single infusion of radiolabeled antibody: 2 mCi (1 mg)
Sponsors
FDA Office of Orphan Products Development
University of Tennessee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of AL amyloidosis
Exclusion criteria
* New York Heart Association class IV * patient on renal dialysis * serum antibodies to mouse protein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radioimmunoimaging of AL amyloid deposits by PET/CT | 10-14 days post infusion |
Countries
United States
Outcome results
None listed