AL Amyloidosis Clinical Trial

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Radioimmunoimaging of AL Amyloidosis

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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.

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Full 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, over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 or 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

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Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of AL Amyloidosis

Exclusion Criteria:

New York Heart Association class IV
patient on renal dialysis
serum antibodies to mouse protein

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

38

Study ID:

NCT01409148

Recruitment Status:

Completed

Sponsor:

University of Tennessee

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There is 1 Location for this study

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University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

38

Study ID:

NCT01409148

Recruitment Status:

Completed

Sponsor:


University of Tennessee

How clear is this clinincal trial information?

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