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

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: [18F]Florbetaben

• Registration Number: NCT03779815
• Lead Sponsor: Ulsan University Hospital

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.

Study Timeline

• Study Start: 2018-08-20
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]Florbetaben PET/CT imaging	[18F]Florbetaben	* 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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of