Radioimmunoimaging of AL Amyloidosis

This study has been completed.
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Alan Solomon, University of Tennessee
ClinicalTrials.gov Identifier:
NCT01409148
First received: July 28, 2011
Last updated: October 10, 2012
Last verified: August 2011

July 28, 2011
October 10, 2012
November 2008
March 2012   (final data collection date for primary outcome measure)
Radioimmunoimaging of AL amyloid deposits [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01409148 on ClinicalTrials.gov Archive Site
Imaging of amyloid deposits as determined by PET/CT [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Radioimmunoimaging of AL Amyloidosis
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
AL Amyloidosis
Biological: 124I-labeled monoclonal antibody Mu 11-1F4
Single infusion of radiolabeled antibody: 2mCi (1 mg)
I-124 Mu 11-1F4 sterile injection
Single arm study
Intervention: Biological: 124I-labeled monoclonal antibody Mu 11-1F4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of AL Amyloidosis

Exclusion Criteria:

  • New York Heart Association class IV
  • patient on renal dialysis
  • serum antibodies to mouse protein
Both
21 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01409148
2625A, FD-R-003420-01-A1
No
Alan Solomon, University of Tennessee
University of Tennessee
Food and Drug Administration (FDA)
Not Provided
University of Tennessee
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP