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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01815086 |
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Date of registration:
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13/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Radioimmunoimaging of Light Chain (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 (mAb) Murine (Mu) 11-F4 |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01815086 |
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Study type:
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Interventional |
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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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Key inclusion & exclusion 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
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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AL Amyloidosis
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Intervention(s)
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Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
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Primary Outcome(s)
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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.
[Time Frame: Five days post PET/CT scan]
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Secondary ID(s)
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1 RO1 FD003420-01A1
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IND 100472
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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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