Radioimmunoimaging of Light Chain (AL) Amyloidosis

This study is currently recruiting participants.

Verified April 2013 by University of Tennessee

Sponsor:

Information provided by (Responsible Party):

Alan Solomon, FDA Office of Orphan Products Development

ClinicalTrials.gov Identifier:

NCT01815086

First received: March 13, 2013

Last updated: April 16, 2013

Last verified: April 2013

History of Changes

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:	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 (mAb) Murine (Mu) 11-F4

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:

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 ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	October 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

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815086

Contacts

Contact: Alan Solomon, MD

865-305-9167

asolomon@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

Sponsors and Collaborators

University of Tennessee

More Information

No publications provided

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, 1 RO1 FD003420-01A1
Study First Received:	March 13, 2013
Last Updated:	April 16, 2013
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

ClinicalTrials.gov processed this record on May 16, 2013

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