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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
History of Changes
  Purpose

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.


Condition Intervention Phase
AL Amyloidosis
 Biological: 124I-labeled monoclonal antibody Mu 11-1F4
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4

Resource links provided by NLM:

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Radioimmunoimaging of AL amyloid deposits [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Imaging of amyloid deposits as determined by PET/CT [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I-124 Mu 11-1F4 sterile injection
Single arm study
 Biological: 124I-labeled monoclonal antibody Mu 11-1F4
Single infusion of radiolabeled antibody: 2mCi (1 mg)

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409148

Locations
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University of Tennessee
Food and Drug Administration (FDA)
  More Information

No publications provided

Responsible Party: Alan Solomon, Professor of Medicine, University of Tennessee
ClinicalTrials.gov Identifier: NCT01409148     History of Changes
Other Study ID Numbers: 2625A, FD-R-003420-01-A1
Study First Received: July 28, 2011
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Tennessee:
Radioimmunoimaging
AL Amyloidosis
PET/CT

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Antibodies
Immunoglobulins
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013