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

Multiple Myeloma Clinical Trial

— PET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779815
• Other study ID #: UUH-2018-05-034-001
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Adverse events	Adverse events will be monitored.	Up to 28 days after [18F]Florbetaben PET/CT scanning