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Radioimmunoimaging of AL Amyloidosis

This study has been completed.
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
Alan Solomon, University of Tennessee Identifier:
First received: December 11, 2008
Last updated: September 17, 2013
Last verified: September 2013
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
Primary Amyloidosis Biological: 124I-labeled monoclonal antibody Mu 11-1F4 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Alan Solomon, University of Tennessee:

Primary Outcome Measures:
  • Radioimmunoimaging of AL amyloid deposits by PET/CT [ Time Frame: 10-14 days post infusion ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: July 2013
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: 2 mCi (1 mg)
Other Name: anti-amyloid radioimmunoimaging agent

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, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 to 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00807872

United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University of Tennessee
FDA Office of Orphan Products Development
Principal Investigator: Alan Solomon, MD University of Tennessee Graduate School of Medicine
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alan Solomon, Alan Solomon, M.D., University of Tennessee Identifier: NCT00807872     History of Changes
Obsolete Identifiers: NCT00808847
Other Study ID Numbers: 2625
Study First Received: December 11, 2008
Last Updated: September 17, 2013

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 processed this record on September 25, 2017