Status:
COMPLETED
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
Lead Sponsor:
Ulsan University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
\[18F\]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
Detailed Description
Diagnostic validity of \[18F\]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.
Eligibility Criteria
Inclusion
- Subject is over 19 years old and male or female of any race/ethnicity
- Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist
- Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected
- Subject has voluntarily agreed to participate in the study
Exclusion
- Subject or subject's legally acceptable representative does not provide written informed consent.
- Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of \[18F\]Florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
- Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator.
- Subject has received any investigational drugs or devices within four weeks prior to the study enrollment.
- Subject has been previously included in this study.
- Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
- Subject is allergic to Florbetaben or any of ingredients of Florbetaben
Key Trial Info
Start Date :
August 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03779815
Start Date
August 20 2018
End Date
February 28 2019
Last Update
April 18 2019
Active Locations (1)
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1
Ulsan University Hospital
Ulsan, South Korea