Clinical Trial: Radioimmunoimaging of Light Chain (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 (mAb) Murine (Mu) 11-F4

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 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 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: 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. [ Time Frame: Five days post PET/CT scan ]

Original Primary Outcome: 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 in patients with AL amyloidosis. [ Time Frame: Five days post PET/CT scan ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Tennessee

Dates:
Date Received: March 13, 2013
Date Started: December 2008
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013