Cardiac Amyloidosis Test-retest Imaging (CATI)
Research type
Research Study
Full title
A test-retest study to evaluate the reproducibility of [18F]Florbetaben PET imaging in patients with cardiac amyloidosis and control patients
IRAS ID
1010888
Contact name
Ana Pereira
Contact email
Sponsor organisation
Life Molecular Imaging GmbH
Clinicaltrials.gov Identifier
Research summary
The goal of the study is to check how consistent the results are when repeating a heart scan (called a PET scan) using the radiopharmaceutical [18F]Florbetaben. This procedure is done in 3 groups of people: participants with a heart problem called AL cardiac amyloidosis, Participants with a heart condition called ATTR cardiac amyloidosis and participants with a heart disease, which is not cardiac amyloidosis. Cardiac amyloidosis (CA) is the deposit of an abnormal protein (amyloid) in the heart. Two different types of CA are the amyloid immunoglobulin light chain (AL) and the amyloid transthyretin (ATTR). In both cardiac AL and ATTR amyloidosis, the deposition of the protein amyloid immunoglobulin light chain and amyloid transthyretin (respectively), forms clumps in the tissue of the heart which makes it hard for the heart to work normally. In many patients, the disease is found only late. Reasons for the delayed diagnosis are that the symptoms are usually unspecific, and the diagnosis may require several diagnostic procedures before it is confirmed. In some cases, the final diagnosis requires to get a small piece of heart tissue in an invasive procedure called “endomyocardial biopsy”. This procedure can be uncomfortable and can have serious side effects. Therefore, it is avoided, if possible, even though it is considered the best way to diagnose the disease. It is hoped that in the future PET imaging with [18F]Florbetaben can replace this invasive procedure at least in some patients. This research study will show if PET scans are reproducible. The study is planned to take place in 2 hospitals in the United Kingdom. Up to 15 patients should undergo the study: 5 AL cardiac amyloidosis, 5 ATTR cardiac amyloidosis patients, and 5 control patients. Participants will undergo 3 visits over approximately 2-3 months. The trial is initiated and organized by the German company Life Molecular Imaging GmbH. Further questions about this study can be forwarded to cati@life-mi.com
REC name
Wales REC 2
REC reference
25/WA/0045
Date of REC Opinion
26 Mar 2025
REC opinion
Further Information Favourable Opinion