Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00807872 |
Date of registration:
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11/12/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Radioimmunoimaging of AL Amyloidosis
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Scientific title:
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Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4 |
Date of first enrolment:
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December 2008 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00807872 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Alan Solomon, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Tennessee Graduate School of Medicine |
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Key inclusion & exclusion 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
Age minimum:
21 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Amyloidosis
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Intervention(s)
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Biological: 124I-labeled monoclonal antibody Mu 11-1F4
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Primary Outcome(s)
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Radioimmunoimaging of AL amyloid deposits by PET/CT
[Time Frame: 10-14 days post infusion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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