Radioimmunoimaging of AL Amyloidosis

AL Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409148
• Other study ID #: 2625A
• Secondary ID: FD-R-003420-01-A
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2011
• Last updated: October 10, 2012
• Start date: November 2008
• Est. completion date: March 2012

Study information

• Verified date: August 2011
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• AL Amyloidosis
• Amyloidosis

Intervention

Biological:
• 124I-labeled monoclonal antibody Mu 11-1F4
Single infusion of radiolabeled antibody: 2mCi (1 mg)

Locations

Country	Name	City	State
United States	University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radioimmunoimaging of AL amyloid deposits		36 months	No
Secondary	Imaging of amyloid deposits as determined by PET/CT		10-14 days	No

External Links

•   Amyloid research foundation