Clinical trial NCT03779815: Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography
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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: multiple myeloma
amyloidosis
Florbetaben
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: sensitivity and specificity per patient analysis
timeFrame: Up to 6 months after [18F]Florbetaben PET/CT scanning
Secondary outcomes:
measure: sensitivity and specificity per organ analysis
timeFrame: Up to 6 months after [18F]Florbetaben PET/CT scanning
measure: Correlation with severity
timeFrame: Up to 6 months after [18F]Florbetaben PET/CT scanning
measure: Adverse events
timeFrame: Up to 28 days after [18F]Florbetaben PET/CT scanning
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Jae-Cheol Jo, PhD
role: PRINCIPAL_INVESTIGATOR
References: