Overview

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

Status:
Completed
Trial end date:
2019-02-28
Target enrollment:
0
Participant gender:
All
Summary
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ulsan University Hospital
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