Radioimmunoimaging of Light Chain (AL) Amyloidosis

AL Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815086
• Other study ID #: IND 100472
• Secondary ID: 1 RO1 FD003420-0
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2013
• Last updated: September 17, 2013
• Start date: December 2008
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• 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 (mAb) 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of AL amyloidosis.

Exclusion Criteria:

• New York Heart Association class IV

• On renal dialysis

• Serum antibodies to mouse protein

Study Design

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:
• Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	PET/CT images will be taken 2 and 5 days post-radiolabeled antibody infusion to evaluate if there is organ/tissue uptake (greater than blood pool) and to determine if the presence of radiolabeled antibody correlates with clinically proven amyloid deposition.	Five days post PET/CT scan	Yes