Life Molecular Imaging Announces Start of Phase 3 Study with [18F]Florbetaben in Cardiac Amyloid Light Chain (AL) Amyloidosis

Enabling an Imaging-based Diagnosis of Cardiac Amyloidosis


BERLIN, Germany, February 7, 2023 – Life Molecular Imaging (LMI) announces today that the first patient has been imaged with [18F]florbetaben in the CArdiag Phase 3 clinical study. This is an open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the diagnostic efficacy of [18F]florbetaben Positron Emission Tomography (PET) imaging to diagnose cardiac AL amyloidosis in patients with suspected cardiac amyloidosis.

The CArdiag Phase 3 clinical program will be performed in Germany, Spain, UK and US – and will enroll approximately 200 patients globally. The primary objective is to determine the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis compared to standard of care clinical diagnosis.

[18F]florbetaben PET is validated and approved to detect neuritic beta amyloid plaques in the brain and available via a global supply network marketed as Neuraceq®. Initial clinical data showed that amyloid deposits of other origin in the heart, such as AL amyloid and transthyretin (TTR) amyloid, can also be detected. Based on these data, the European Commission and the U.S. Food and Drug Administration granted orphan drug designation to [18F]florbetaben in 2020 as a diagnostic tool for AL amyloidosis. The detection of amyloid deposits in the heart will be further investigated and validated in the current Phase 3 trial. Exploratory analyses will evaluate the possibility for a differential diagnosis between the two main types (AL and ATTR) of cardiac amyloidosis by [18F]florbetaben PET.

“Expanding the indication for our amyloid PET tracer from detecting ß-amyloid deposits in the brain to detecting amyloid deposits in the heart in patients with cardiac amyloidosis will allow us to support an earlier diagnosis of this rare and life-threatening disease”, said Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging. “We are proud to announce the start of this Phase 3 study, which marks another milestone on our vision to reduce the burden of disease by improving early diagnosis and characterization of chronic and life-threatening diseases.”

“Cardiac AL amyloidosis is a progressive and life-threatening disease, and its diagnosis and treatment are challenging”, said Dr. Andrew Stephens, MD, PhD, CMO of Life Molecular Imaging. “[18F]florbetaben PET imaging of patients with suspected cardiac amyloidosis has the potential to become an important tool to simplify and shorten the time to diagnosis, providing earlier and appropriate access to therapy and improved monitoring of such interventions.”

Further details of the CArdiag Phase 3 study design are available on (NCT05184088).

About [18F]florbetaben
[18F]florbetaben is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain. [18F]florbetaben has been approved by the FDA and EMA for routine clinical use, and has local regulatory approval in other countries such as Japan and Korea.  It binds to beta sheet structure of amyloid proteins. [18F]florbetaben is marketed as Neuraceq® to estimate the neuritic beta amyloid plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. [18F]florbetaben is currently under investigation as a targeted radiopharmaceutical for the detection of amyloid deposits in the heart and other organs of patients with cardiac and systemic amyloidosis of AL and ATTR type.

Most Common Adverse Reactions
In clinical trials including demented and non-demented subjects, the most frequently observed adverse drug reactions in 872 subjects with 1090 Florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit

About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit

For media queries contact:

Dr Iris Hardewig

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.



  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.


  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).


  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.


  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.