Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• 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