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Radioimmunoimaging of AL Amyloidosis

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ClinicalTrials.gov Identifier: NCT01409148
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : October 11, 2012
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Alan Solomon, University of Tennessee

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Radioimmunoimaging of AL amyloid deposits [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Imaging of amyloid deposits as determined by PET/CT [ Time Frame: 10-14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of AL Amyloidosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409148

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

Additional Information:
Responsible Party: Alan Solomon, Professor of Medicine, University of Tennessee
ClinicalTrials.gov Identifier: NCT01409148     History of Changes
Other Study ID Numbers: 2625A
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: August 2011

Keywords provided by Alan Solomon, University of Tennessee:
AL Amyloidosis

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