NCT01815086

Radioimmunoimaging of Light Chain (AL) Amyloidosis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 (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.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
BIOLOGICAL	Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)	Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-03-20
• Last updated: 2013-09-18

Locations

1 site across 1 country: United States