Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Tennessee
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Radioimmunoimaging of AL amyloid deposits
Study Overview
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, over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 or 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Radioimmunoimaging of AL amyloid deposits
Time Frame: 36 months
Secondary Outcomes
- Imaging of amyloid deposits as determined by PET/CT(10-14 days)
Investigators
Alan Solomon
Professor of Medicine
University of Tennessee