Radioimmunoimaging of AL Amyloidosis
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4
2 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedOctober 11, 2012
August 1, 2011
3.3 years
July 28, 2011
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radioimmunoimaging of AL amyloid deposits
36 months
Secondary Outcomes (1)
Imaging of amyloid deposits as determined by PET/CT
10-14 days
Study Arms (1)
I-124 Mu 11-1F4 sterile injection
OTHERSingle arm study
Interventions
Single infusion of radiolabeled antibody: 2mCi (1 mg)
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of AL Amyloidosis
You may not qualify if:
- New York Heart Association class IV
- patient on renal dialysis
- serum antibodies to mouse protein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tennesseelead
- Food and Drug Administration (FDA)collaborator
Study Sites (1)
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 4, 2011
Study Start
November 1, 2008
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 11, 2012
Record last verified: 2011-08