NCT00807872

Radioimmunoimaging of AL Amyloidosis

Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Amyloidosis

Interventions

Type	Name	Description
BIOLOGICAL	124I-labeled monoclonal antibody Mu 11-1F4	Single infusion of radiolabeled antibody: 2 mCi (1 mg)

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-03-01
• Completion: 2013-07-01
• First posted: 2008-12-12
• Last updated: 2013-09-18

Locations

1 site across 1 country: United States