Efficacy of [18F]florbetaben PET for diagnosis of cardiac AL amyloidosis
Research type
Research Study
Full title
An open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the efficacy and safety of [18F]florbetaben Positron Emission Tomography (PET) imaging to diagnose cardiac AL amyloidosis
IRAS ID
1004869
Contact name
Ana Pereira
Contact email
Sponsor organisation
Life Molecular Imaging GmbH
Eudract number
2022-000117-14
Clinicaltrials.gov Identifier
Research summary
The study is focused on determining the diagnostic efficacy of a nuclear medicine procedure, the [18F]florbetaben Positron Emission Tomography (FBB PET) imaging, for the diagnosis of cardiac AL amyloidosis in patients with suspected cardiac amyloidosis.
Cardiac AL amyloidosis is characterized by the deposition of the amyloid immunoglobulin light chain (AL) protein in cardiac tissue. In many patients, this condition is usually detected only late, despite the early diagnosis, and treatment onset is critical for the survival time of patients. Reasons for the belayed diagnosis are that the symptoms are generally unspecific, and that the diagnosis may require several procedures, including an endomyocardial biopsy. Due to its invasive nature and the related discomfort for the patient, many cardiologists try to avoid endomyocardial biopsies, even though they are considered the gold standard for the diagnosis of cardiac amyloidosis. Therefore, the FBB PET imaging may replace this invasive procedure at least in some patients in the future, offering the possible benefit of a more accurate and earlier diagnosis of cardiac AL.
Patients with suspected cardiac amyloidosis or with a diagnosis of amyloidosis but with unclear involvement of the heart will be enrolled in this study after being screened by their physician at the hospital. All enrolled patients will undergo FBB PET imaging and the other diagnostic procedures that belong to the standard routine care, for approximately 2 months. For this trial, the information, and results from all diagnostic procedures until the final diagnosis regarding cardiac amyloidosis will be collected. These results will be compared to the ones obtained from FBB PET to determine its efficacy.
Life Molecular Imaging GmbH is sponsoring this study which aims to recruit 200 patients and will run in 10-13 centers in the United Kingdom, United States, Germany, and Spain. Further questions about this study can be forwarded to cardiag@life-mi.com.REC name
London - Riverside Research Ethics Committee
REC reference
22/LO/0413
Date of REC Opinion
8 Jul 2022
REC opinion
Further Information Favourable Opinion