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Radioimmunoimaging of Light Chain (AL) Amyloidosis

NCT ID: NCT01815086

Last Updated: 2013-09-18

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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, 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.

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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)

Intervention Type BIOLOGICAL

Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)

Interventions

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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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Alan Solomon

Professor of Mediciine; Head, Human Immunology & Cancer Program

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

Other Identifiers

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1R01FD003420-01A1

Identifier Type: FDA

Identifier Source: secondary_id

View Link

IND 100472

Identifier Type: -

Identifier Source: org_study_id