Radioimmunoimaging of AL Amyloidosis

University of Tennessee

Status and phase: Completed; Phase 1

Conditions: AL Amyloidosis

Treatments: Biological: 124I-labeled monoclonal antibody Mu 11-1F4

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01409148

2625A

FD-R-003420-01-A1

Details and patient eligibility

About

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.

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.

Enrollment: 38 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of AL Amyloidosis

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

I-124 Mu 11-1F4 sterile injection

Other group

Description:

Single arm study

Treatment:

Biological: 124I-labeled monoclonal antibody Mu 11-1F4