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Radioimmunoimaging of Light Chain (AL) Amyloidosis

Primary Purpose

AL Amyloidosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for AL Amyloidosis focused on measuring Radioimmunoimaging, AL Amyloidosis, PET/CT

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Tennessee Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

124I-labeled anti-amyloid mAb 11-1F4

Arm Description

124I-labeled anti-amyloid mAb 11-1F4 will be infused on day 0. Two and 5 days later, PET/CT scans will be performed.

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
September 17, 2013
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT01815086
Brief Title
Radioimmunoimaging of Light Chain (AL) Amyloidosis
Official Title
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AL Amyloidosis
Keywords
Radioimmunoimaging, AL Amyloidosis, PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
124I-labeled anti-amyloid mAb 11-1F4
Arm Type
Experimental
Arm Description
124I-labeled anti-amyloid mAb 11-1F4 will be infused on day 0. Two and 5 days later, PET/CT scans will be performed.
Intervention Type
Biological
Intervention Name(s)
Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Intervention Description
Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Five days post PET/CT scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

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Radioimmunoimaging of Light Chain (AL) Amyloidosis

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