None listed
Conditions
Interventions
Drug : "
Drug: [18F]Florbetaben
[18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma
Other name: Florbetaben"
Amount: 300 MBq ± 20%
bolus, 10mL intraveously
Sponsors
Ulsan Univeristy Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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]FSPG 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 hyoscine butylbromide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis | — |
Countries
Korea, Republic of
Contacts
Public ContactMin Jeong Seo
Ulsan Univeristy Hospital
Outcome results
None listed