Radioimmunoimaging of AL Amyloidosis

This study is currently recruiting participants.

Verified November 2011 by University of Tennessee

First Received on December 11, 2008. Last Updated on November 21, 2011 History of Changes

Sponsor:	University of Tennessee
Collaborator:	FDA Office of Orphan Products Development
Information provided by (Responsible Party):	Alan Solomon, University of Tennessee
ClinicalTrials.gov Identifier:	NCT00807872

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
Primary Amyloidosis	Biological: 124I-labeled monoclonal antibody Mu 11-1F4	Phase I

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

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:

Radioimmunoimaging of AL amyloid deposits by PET/CT [ Time Frame: 10-14 days post infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	September 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.

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: NCT00807872

Contacts

Contact: Alan Solomon, MD	(865) 305-9167	asolomon@utmck.edu
Contact: Jonathan S. Wall, PhD	(865) 305-5547	jwall@utmck.edu

Locations

United States, Tennessee
University of Tennessee Medical Center	Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Alan Solomon, MD 865-305-9167 asolomon@utmck.edu
Principal Investigator: Alan Solomon, MD

Sponsors and Collaborators

University of Tennessee

FDA Office of Orphan Products Development

Investigators

Principal Investigator:

Alan Solomon, MD

University of Tennessee Graduate School of Medicine

More Information

Additional Information:

Amyloid Research Foundation This link exits the ClinicalTrials.gov site

No publications provided by University of Tennessee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wall JS, Kennel SJ, Stuckey AC, Long MJ, Townsend DW, Smith GT, Wells KJ, Fu Y, Stabin MG, Weiss DT, Solomon A. Radioimmunodetection of amyloid deposits in patients with AL amyloidosis. Blood. 2010 Sep 30;116(13):2241-4. Epub 2010 Jun 3.

Responsible Party:	Alan Solomon, Alan Solomon, M.D., University of Tennessee
ClinicalTrials.gov Identifier:	NCT00807872 History of Changes
Obsolete Identifiers:	NCT00808847
Other Study ID Numbers:	2625, FD-R-003420-01-A1
Study First Received:	December 11, 2008
Last Updated:	November 21, 2011
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 February 09, 2012