Overview
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-09-01
2024-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Life Molecular Imaging GmbH
Criteria
Inclusion Criteria:- Males and females age ≥18 years
- Able to understand, sign and date written informed consent
- Written informed consent must be obtained before any assessment is performed
- Subjects being considered for a possible diagnosis of cardiac amyloidosis
- Any of the following conditions:
- Established systemic amyloidosis without proven cardiac involvement, OR
- Known plasma cell dyscrasia (MGUS, multiple myeloma), OR
- Pathological free light chain levels in urine or serum, OR
- Presence of heart failure with preserved ejection fraction
- In combination with at least one of the following parameters, indicative of cardiac
manifestation:
- Mean (left ventricular (LV) wall + septum) thickness >12mm as measured by
echocardiography in absence of other known cause of left ventricular hypertrophy
(LVH), OR
- NT-proBNP >335 ng/L
- Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g.,
endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic
resonance imaging or echocardiography)
- Female subjects must be documented by medical records or physician's note to be either
surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral
oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without
an alternative medical cause). If they are of child-bearing potential, must commit to
use of a highly effective contraceptive measure for at least one week following the
PET scan
- Male subjects and their partners of childbearing potential must commit to the use of a
highly effective method of contraception for a minimum of 90 days following the PET
scan
- Male subjects must commit to not donate sperm for a minimum of 90 days after the PET
scan
Exclusion Criteria:
- Any concurrent medical condition or disease that would likely interfere with study
procedures or results
- Inability to lay flat for up to 60 min
- Pregnant, lactating or breastfeeding
- Unwilling and/or unable to cooperate with study procedures
- Having been administered a radiopharmaceutical within 10 radioactive half-lives prior
to study drug administration in this study