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Radioimmunoimaging of AL Amyloidosis

NCT ID: NCT01409148

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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AL Amyloidosis

Keywords

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Radioimmunoimaging AL Amyloidosis PET/CT

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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I-124 Mu 11-1F4 sterile injection

Single arm study

Group Type OTHER

124I-labeled monoclonal antibody Mu 11-1F4

Intervention Type BIOLOGICAL

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

Interventions

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124I-labeled monoclonal antibody Mu 11-1F4

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of AL Amyloidosis

Exclusion Criteria

* New York Heart Association class IV
* patient on renal dialysis
* serum antibodies to mouse protein
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Alan Solomon

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://[email protected]

Amyloid research foundation

Other Identifiers

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FD-R-003420-01-A1

Identifier Type: -

Identifier Source: secondary_id

2625A

Identifier Type: -

Identifier Source: org_study_id