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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

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: [18F]Florbetaben Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 20, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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 Name: neuraceq




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Adverse events [ Time Frame: Up to 28 days after [18F]Florbetaben PET/CT scanning ]
    Adverse events will be monitored.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779815


Locations
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Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Ulsan University Hospital
Investigators
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Principal Investigator: Jae-Cheol Jo, PhD Ulsan University Hospital

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Responsible Party: Jae-Cheol Jo, Assistant professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT03779815     History of Changes
Other Study ID Numbers: UUH-2018-05-034-001
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Jae-Cheol Jo, Ulsan University Hospital:
multiple myeloma
amyloidosis
Florbetaben

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Amyloidosis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases