Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography

Study Overview
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Brief Summary
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[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.

Detailed Description
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Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.

Official Title
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A Pilot Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]Florbetaben Positron Emission Tomography for Detecting Amyloidosis in Multiple Myeloma Patients

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: [18F]Florbetaben


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]Florbetaben PET/CT imaging<br>Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected) Intravenous injection of [18F]Florbetaben and PET/CT scanning Intervention: Drug ([18F]Florbetaben) | Drug: [18F]Florbetaben<br>* Drug: [18F]Florbetaben [18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma Other name: Neuraceq Amount: 300 MBq ± 20% bolus, 10mL intravenously<br>* Other names: neuraceq;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity per patient analysis | Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis | Up to 6 months after [18F]Florbetaben PET/CT scanning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity per organ analysis | Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis | Up to 6 months after [18F]Florbetaben PET/CT scanning | 
| Correlation with severity | Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity | Up to 6 months after [18F]Florbetaben PET/CT scanning | 
| Adverse events | Adverse events will be monitored. | Up to 28 days after [18F]Florbetaben PET/CT scanning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple myeloma, amyloidosis, Florbetaben