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

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: [18F]Florbetaben

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]Florbetaben PET/CT imaging; 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; Drug: [18F]Florbetaben; [18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma; Other name: Neuraceq; Amount: 300 MBq ± 20% bolus, 10mL intravenously; Other Names: neuraceq

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Principal Investigator: Jae-Cheol Jo, PhD, Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: December 16, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: amyloidosis; multiple myeloma; Florbetaben
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Proteostasis Deficiencies; Multiple Myeloma; Neoplasms, Plasma Cell; Amyloidosis
• Other Study ID Numbers: UUH-2018-05-034-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No