Radioimmunoimaging of Light Chain (AL) Amyloidosis
- Conditions
- AL Amyloidosis
- Registration Number
- NCT01815086
- Lead Sponsor
- University of Tennessee
- Brief Summary
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) 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 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
- 30
- Patients with a confirmed diagnosis of AL amyloidosis.
- New York Heart Association class IV
- On renal dialysis
- Serum antibodies to mouse protein
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determination of the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT in up to 30 patients with AL amyloidosis. Five days post PET/CT scan PET/CT images will be taken 2 and 5 days post-radiolabeled antibody infusion to evaluate if there is organ/tissue uptake (greater than blood pool) and to determine if the presence of radiolabeled antibody correlates with clinically proven amyloid deposition.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States