Status:
COMPLETED
Radioimmunoimaging of AL Amyloidosis
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Primary Amyloidosis
Eligibility:
All Genders
21-90 years
Phase:
PHASE1
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 patien...
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. Addit...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of AL amyloidosis
Exclusion
- New York Heart Association class IV
- patient on renal dialysis
- serum antibodies to mouse protein
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00807872
Start Date
December 1 2008
End Date
July 1 2013
Last Update
September 18 2013
Active Locations (1)
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1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920