Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic
 amyloidosis.
Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in
 subjects with multiple myeloma.
Inclusion Criteria:

 -  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 Criteria:

 -  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