Multiple Myeloma
Conditions
Keywords
multiple myeloma, amyloidosis, Florbetaben
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.
Interventions
DRUG[18F]Florbetaben
* Drug: \[18F\]Florbetaben * \[18F\]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma * Other name: Neuraceq * Amount: 300 MBq ± 20% bolus, 10mL intravenously
Sponsors
Ulsan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity per patient analysis | Up to 6 months after [18F]Florbetaben PET/CT scanning | 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 | Description |
|---|---|---|
| sensitivity and specificity per organ analysis | Up to 6 months after [18F]Florbetaben PET/CT scanning | Sensitivity and specificity of \[18F\]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis |
| Correlation with severity | Up to 6 months after [18F]Florbetaben PET/CT scanning | Correlation of \[18F\]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity |
| Adverse events | Up to 28 days after [18F]Florbetaben PET/CT scanning | Adverse events will be monitored. |
Countries
South Korea
Outcome results
None listed