Skip to main content
OpenTrials
Completed

NCT Number: NCT01409148

Radioimmunoimaging of AL Amyloidosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

AL Amyloidosis Amyloidosis Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of AL Amyloidosis

Exclusion criteria

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

Treatment and study plan

124I-labeled monoclonal antibody Mu 11-1F4

Biological

Single infusion of radiolabeled antibody: 2mCi (1 mg)

Primary outcomes

  1. Radioimmunoimaging of AL amyloid deposits

    Time frame: 36 months

Secondary outcomes

  1. Imaging of amyloid deposits as determined by PET/CT

    Time frame: 10-14 days

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2011
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.