Florbetaben PET for Cardiac Amyloidosis
(CArdiag Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Life Molecular Imaging GmbH
Disqualifiers: Severe hepatic impairment, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug [18F]florbetaben (Neuraceq) for cardiac amyloidosis?
How does the drug Florbetaben PET differ from other treatments for cardiac amyloidosis?
Florbetaben PET is unique because it uses a radioactive tracer to visualize amyloid deposits in the heart, which helps in diagnosing cardiac amyloidosis. Unlike traditional treatments that focus on managing symptoms, this approach provides a non-invasive way to detect the disease early by highlighting amyloid plaques, similar to its use in Alzheimer's disease diagnosis.12467
Eligibility Criteria
This trial is for adults who may have cardiac amyloidosis, a heart condition where abnormal proteins build up. Participants should be over 18, able to consent, and suspected of having this condition due to symptoms like heart failure with preserved ejection fraction or thickened heart walls without other known causes.Inclusion Criteria
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 by one of the following conditions: Established systemic amyloidosis without proven cardiac involvement, Known plasma cell dyscrasia (MGUS, multiple myeloma), Pathological free light chain levels in urine or serum, Presence of heart failure with preserved ejection fraction AND 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), 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/echocardiography or bone scintigraphy), 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, they 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
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Exclusion Criteria
I haven't had radiopharmaceutical treatment recently.
Any known allergic reactions or hypersensitivity towards any compound of the study drug
Pregnant, lactating or breastfeeding
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Diagnostic Imaging
Participants undergo a single application of 300 MBq [18F]florbetaben and PET scanning to assess cardiac amyloidosis
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging, including assessment of adverse events
17 days
Extended Follow-up
Further assessments of diagnostic impact and correlation with clinical parameters
Up to 14 weeks
Treatment Details
Interventions
- [18F]florbetaben (Radiopharmaceutical)
Trial Overview[18F]florbetaben PET scans are being tested in this Phase 3 study to see if they can accurately diagnose cardiac amyloidosis. Patients will receive a single dose of the tracer and undergo PET imaging at multiple centers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patients with suspected cardiac amyloidosisExperimental Treatment1 Intervention
After enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
St Luke's HospitalKansas City, KS
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?
Life Molecular Imaging GmbHLead Sponsor
pharmtrace klinische Entwicklung GmbHCollaborator
References
18F-florbetaben whole-body PET/MRI for evaluation of systemic amyloid deposition. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Florbetaben, a 18F-labeled stilbene derivative (Neuraceq®, formerly known as BAY-949172), is a diagnostic radiopharmaceutical developed to visualize β-amyloid plaques in the brain. Here, we report a pilot study evaluating patients with suspected cardiac amyloidosis for systemic extent of disease.
Cardiac Amyloid Imaging with 18F-Florbetaben PET: A Pilot Study. [2017]Our aim was to determine the feasibility of 18F-florbetaben PET in diagnosing cardiac amyloidosis.
Detection of cardiac amyloidosis with 18F-Florbetaben-PET/CT in comparison to echocardiography, cardiac MRI and DPD-scintigraphy. [2020]Label="PURPOSE" NlmCategory="OBJECTIVE">Cardiac amyloidosis (CA) is a rare cause of heart failure with frequently delayed diagnosis, because specific early signs or symptoms are missing. Recently, direct amyloid imaging using positron emission tomography/computed tomography (PET/CT) has emerged. The aim of this study was to examine the performance of 18F-florbetaben-PET/CT in detection of CA, and compare it to echocardiography (echo), cardiac MRI (CMR) and scintigraphy. Additionally, the use of 18F-florbetaben-PET/CT for quantification of amyloid burden and monitoring of treatment response was assessed.
Pilot Study of F18-Florbetapir in the Early Evaluation of Cardiac Amyloidosis. [2021]Background: Cardiac amyloidosis is an increasingly recognized etiology of heart failure, in part due to the rise of non-invasive nuclear bone scintigraphy. Molecular imaging using positron emission tomography (PET) has promised the direct visualization of cardiac amyloid fibrils. We sought to assess the performance of F18-florbetapir PET in patients with a potential for cardiac amyloidosis in order to identify early disease. Methods: We performed a pilot study of 12 patients: one with asymptomatic transthyretin cardiac amyloidosis, seven with a potential for developing cardiac amyloidosis (two smoldering myeloma and five with extracardiac biopsy demonstrating transthyretin amyloid deposits and negative technetium pyrophosphate scans), and four controls. Patients were imaged with PET/CT in listmode 10-20 min after receiving F18-florbetapir. Static images were created from this acquisition, and mean standardized uptake values (SUVs) of the left ventricular myocardium, blood pool, paraspinal muscles, and liver were calculated. Results: All 12 patients demonstrated radiotracer uptake in the myocardium with mean SUV of 2.3 ± 0.4 and blood pool SUV of 0.8 ± 0.1. The patient with cardiac amyloidosis had SUV of 3.3, while mean SUV for patients at risk was 2.3 ± 0.4 and for controls was 2.2 ± 0.3. After 3 years of follow-up, one patient with SUV below the mean was subsequently diagnosed with ATTR cardiac amyloidosis. Conclusion: In this cohort, PET with F18-florbetapir demonstrated non-specific radiotracer uptake in the myocardium in all patients using a static image protocol; though, the highest values were noted in a patient with ATTR cardiac amyloidosis. There was no difference in the intensity of F18-florbetapir uptake in at-risk patients and controls. Future studies should continue to investigate metabolic PET tracers and protocols in cardiac amyloidosis, including in early disease.
Imaging cardiac amyloidosis: a pilot study using ¹⁸F-florbetapir positron emission tomography. [2021]Cardiac amyloidosis, a restrictive heart disease with high mortality and morbidity, is underdiagnosed due to limited targeted diagnostic imaging. The primary aim of this study was to evaluate the utility of (18)F-florbetapir for imaging cardiac amyloidosis.
[(18)F]Florbetaben: a review in β-amyloid PET imaging in cognitive impairment. [2022]Intravenous (18)F-labelled florbetaben ([(18)F]florbetaben) [Neuraceq™] is a polyethylene glycol stilbene derivative that is approved in the USA, EU and South Korea for positron emission tomography (PET) imaging of the brain. It is used to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment. In vitro, [(18)F]florbetaben has high affinity and selectivity for β-amyloid. It has a short PET scan time (15-20 min). Visual assessment of regional and whole brain [(18)F]florbetaben PET images detected brain β-amyloid with high sensitivity and specificity, with good inter-reader agreement, in a phase III study in patients with various levels of cognitive function when compared with postmortem histopathological assessment. The whole brain visual assessment displayed high positive and negative predictive values, enabling amyloid pathology to be reliably detected or excluded. Quantitative PET analyses were generally consistent with the visual assessments. [(18)F]florbetaben was generally well tolerated in clinical trials. All adverse reactions in [(18)F]florbetaben recipients were mild to moderate in severity and the most common were injection-site-related (erythema, irritation and pain). There were no serious adverse reactions related to [(18)F]florbetaben. In summary, [(18)F]florbetaben is a highly accurate β-amyloid PET tracer that has the potential to support the clinical diagnosis of Alzheimer's disease and other causes of cognitive decline.
PET-CT evaluation of amyloid systemic involvement with [18F]-florbetaben in patient with proved cardiac amyloidosis: a case report. [2019]Label="BACKGROUND">One of the most frequent disorders which lead to cardiac amyloidosis is transthyretin-related amyloidosis (ATTR). Some PET radio-pharmaceuticals for the detection of beta-amyloid deposits within the brain have shown to be able to detect also cardiac amyloid deposits. We present a case of a man with ATTR studied with [18F]-florbetaben PET-CT.