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

Ulsan University Hospital

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: [18F]Florbetaben

Study type: Interventional

Funder types: Other

Identifiers

NCT03779815

UUH-2018-05-034-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

[18F]Florbetaben PET/CT imaging

Experimental group

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)

Treatment:

Drug: [18F]Florbetaben