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

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ClinicalTrials.gov Identifier: NCT03779815
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jae-Cheol Jo, Ulsan University Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE August 20, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2018)
sensitivity and specificity per patient analysis [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03779815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2018)
  • sensitivity and specificity per organ analysis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 28 days after [18F]Florbetaben PET/CT scanning ]
    Adverse events will be monitored.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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 Name: neuraceq
Study Arms  ICMJE 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)
Intervention: Drug: [18F]Florbetaben
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2018)
18
Actual Study Completion Date  ICMJE February 28, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03779815
Other Study ID Numbers  ICMJE UUH-2018-05-034-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jae-Cheol Jo, Ulsan University Hospital
Study Sponsor  ICMJE Ulsan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Cheol Jo, PhD Ulsan University Hospital
PRS Account Ulsan University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP