- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409148
Radioimmunoimaging of AL Amyloidosis
October 10, 2012 updated by: Alan Solomon, University of Tennessee
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
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Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of AL Amyloidosis
Exclusion Criteria:
- New York Heart Association class IV
- patient on renal dialysis
- serum antibodies to mouse protein
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: I-124 Mu 11-1F4 sterile injection
Single arm study
|
Single infusion of radiolabeled antibody: 2mCi (1 mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radioimmunoimaging of AL amyloid deposits
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Imaging of amyloid deposits as determined by PET/CT
Time Frame: 10-14 days
|
10-14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
July 28, 2011
First Submitted That Met QC Criteria
August 3, 2011
First Posted (ESTIMATE)
August 4, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 11, 2012
Last Update Submitted That Met QC Criteria
October 10, 2012
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Paraproteinemias
- Proteostasis Deficiencies
- Neoplasms, Plasma Cell
- Immunoglobulin Light-chain Amyloidosis
- Amyloidosis
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Antibodies, Monoclonal
Other Study ID Numbers
- 2625A
- FD-R-003420-01-A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on AL Amyloidosis
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Nexcella Inc.Not yet recruitingLight Chain (AL) AmyloidosisUnited States
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Sorrento Therapeutics, Inc.WithdrawnLight Chain (AL) Amyloidosis
-
European Myeloma NetworkJanssen PharmaceuticaActive, not recruitingLight Chain (AL) Amyloidosis, Stage 3BNetherlands, Greece, France, Italy
-
Peking Union Medical College HospitalRecruitingLight Chain (AL) Amyloidosis | Venetoclax | CCND1 TranslocationChina
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Boston Medical CenterMillennium Pharmaceuticals, Inc.Completed
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Tufts Medical CenterSanofiWithdrawnAmyloidosis | Light Chain (AL) Amyloidosis
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Sorrento Therapeutics, Inc.RecruitingLight Chain (AL) AmyloidosisUnited States
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Weill Medical College of Cornell UniversityJanssen Scientific Affairs, LLCRecruitingAL Amyloidosis | Amyloid | Refractory AL AmyloidosisUnited States
-
IRCCS Policlinico S. MatteoTerminatedCardiac AL AmyloidosisSpain, France, Italy, Germany, Canada, Greece, Turkey, United Kingdom
-
Prothena Biosciences Ltd.RecruitingLight Chain (AL) AmyloidosisUnited States, Korea, Republic of, Australia, Denmark, France, Italy, Spain, Israel, Taiwan, Austria, Canada, Czechia, Germany, Greece, Hungary, Ireland, Japan, Netherlands, Poland, Portugal, Turkey, United Kingdom, Belgium
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