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Radioimmunoimaging of Light Chain (AL) Amyloidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01815086
First Posted: March 20, 2013
Last Update Posted: September 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alan Solomon, FDA Office of Orphan Products Development
  Purpose
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.

Condition Intervention Phase
AL Amyloidosis Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) 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 (mAb) Murine (Mu) 11-F4

Resource links provided by NLM:


Further study details as provided by Alan Solomon, FDA Office of Orphan Products Development:

Primary Outcome Measures:
  • 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. [ Time Frame: Five days post PET/CT scan ]
    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.


Enrollment: 30
Study Start Date: December 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 124I-labeled anti-amyloid mAb 11-1F4
124I-labeled anti-amyloid mAb 11-1F4 will be infused on day 0. Two and 5 days later, PET/CT scans will be performed.
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)

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 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.
  Eligibility

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
Criteria

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
  Contacts and Locations
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): NCT01815086


Locations
United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University of Tennessee
  More Information

Responsible Party: Alan Solomon, Professor of Mediciine; Head, Human Immunology & Cancer Program, FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT01815086     History of Changes
Other Study ID Numbers: IND 100472
1R01FD003420-01A1 ( U.S. FDA Grant/Contract )
First Submitted: March 13, 2013
First Posted: March 20, 2013
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Alan Solomon, FDA Office of Orphan Products Development:
Radioimmunoimaging
AL Amyloidosis
PET/CT

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases