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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
[18F]Florbetaben
Sponsored by
Ulsan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring multiple myeloma, amyloidosis, Florbetaben

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]Florbetaben PET/CT imaging

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Correlation with severity
Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity
Adverse events
Adverse events will be monitored.

Full Information

First Posted
September 12, 2018
Last Updated
April 16, 2019
Sponsor
Ulsan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03779815
Brief Title
Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, amyloidosis, Florbetaben

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[18F]Florbetaben PET/CT imaging
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
[18F]Florbetaben
Other Intervention Name(s)
neuraceq
Intervention Description
Drug: [18F]Florbetaben [18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma Other name: Neuraceq Amount: 300 MBq ± 20% bolus, 10mL intravenously
Primary Outcome Measure Information:
Title
sensitivity and specificity per patient analysis
Description
Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
Time Frame
Up to 6 months after [18F]Florbetaben PET/CT scanning
Secondary Outcome Measure Information:
Title
sensitivity and specificity per organ analysis
Description
Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
Time Frame
Up to 6 months after [18F]Florbetaben PET/CT scanning
Title
Correlation with severity
Description
Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity
Time Frame
Up to 6 months after [18F]Florbetaben PET/CT scanning
Title
Adverse events
Description
Adverse events will be monitored.
Time Frame
Up to 28 days after [18F]Florbetaben PET/CT scanning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Cheol Jo, PhD
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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