Clinical Trial: Radioimmunoimaging of AL Amyloidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Tennessee

Current Primary Outcome: Radioimmunoimaging of AL amyloid deposits by PET/CT [ Time Frame: 10-14 days post infusion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: July 28, 2011
Date Started: November 2008
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013