Radioimmunoimaging of AL Amyloidosis
- Conditions
- AL Amyloidosis
- Interventions
- Biological: 124I-labeled monoclonal antibody Mu 11-1F4
- Registration Number
- NCT01409148
- Lead Sponsor
- University of Tennessee
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Confirmed diagnosis of AL Amyloidosis
- New York Heart Association class IV
- patient on renal dialysis
- serum antibodies to mouse protein
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I-124 Mu 11-1F4 sterile injection 124I-labeled monoclonal antibody Mu 11-1F4 Single arm study
- Primary Outcome Measures
Name Time Method Radioimmunoimaging of AL amyloid deposits 36 months
- Secondary Outcome Measures
Name Time Method Imaging of amyloid deposits as determined by PET/CT 10-14 days
Trial Locations
- Locations (1)
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States