Back to resultsRadioimmunoimaging of AL Amyloidosis
Primary Purpose
AL Amyloidosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
124I-labeled monoclonal antibody Mu 11-1F4
Sponsored by
About this trial
This is an interventional diagnostic trial for AL Amyloidosis focused on measuring Radioimmunoimaging, AL Amyloidosis, PET/CT
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of AL Amyloidosis
Exclusion Criteria:
- New York Heart Association class IV
- patient on renal dialysis
- serum antibodies to mouse protein
Sites / Locations
- University of Tennessee Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
I-124 Mu 11-1F4 sterile injection
Arm Description
Single arm study
Outcomes
Primary Outcome Measures
Radioimmunoimaging of AL amyloid deposits
Secondary Outcome Measures
Imaging of amyloid deposits as determined by PET/CT
Full Information
NCT ID
NCT01409148
First Posted
July 28, 2011
Last Updated
October 10, 2012
Sponsor
University of Tennessee
Collaborators
Food and Drug Administration (FDA)
1. Study Identification
Unique Protocol Identification Number
NCT01409148
Brief Title
Radioimmunoimaging of AL Amyloidosis
Official Title
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee
Collaborators
Food and Drug Administration (FDA)
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 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, 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.
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
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-124 Mu 11-1F4 sterile injection
Arm Type
Other
Arm Description
Single arm study
Intervention Type
Biological
Intervention Name(s)
124I-labeled monoclonal antibody Mu 11-1F4
Intervention Description
Single infusion of radiolabeled antibody: 2mCi (1 mg)
Primary Outcome Measure Information:
Title
Radioimmunoimaging of AL amyloid deposits
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Imaging of amyloid deposits as determined by PET/CT
Time Frame
10-14 days
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:
Confirmed diagnosis of AL Amyloidosis
Exclusion Criteria:
New York Heart Association class IV
patient 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
Links:
URL
http://www.ARFAmyloid@aol.com
Description
Amyloid research foundation
Learn more about this trial
Radioimmunoimaging of AL Amyloidosis
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