Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography (PET)
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Layout table for eligibility information
Ages Eligible for Study:
19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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