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Also known as Florbetaben (BAY94-9172), [18F]florbetaben
Florbetaben · 5 trials · 6 indications
The results from the visual assessment of \[18F\]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.
The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as "normal" or "abnormal" depending on the presence or absence of regional tracer uptake in the respective region. "Normal" therefore meant absence of β-amyloid and "abnormal" presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "β-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "β-amyloid not present".
The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.
Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis. Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used. Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of "1" (without beta-amyloid plaque load) or "2" (with minor beta-amyloid plaque load) was considered normal and a BAPL score of "3" (with significant beta-amyloid plaque load) was considered abnormal. Using algorithm B (Average), a brain scan of a subject with a BAPL score of "1" was considered normal and a brain scan with a BAPL score of "2" or "3" was considered abnormal. Algorithm B was used in Part B and in the final
Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores "2" or "3") which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score "1") which was considered a match for specificity. The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia. Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media.
Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)
| Arm | Type | Description |
|---|---|---|
| Patients with suspected cardiac amyloidosis | EXPERIMENTAL | 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. |
| Florbetaben (BAY94-9172) | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [18F]florbetaben | DRUG | All enrolled patients will undergo \[18F\]florbetaben PET imaging. |
| Florbetaben (BAY94-9172) | DRUG | Single intravenous injection 1-5ml, 300 MBq (+/- 20%) |
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 study procedures are performed * Subjects being considered for a possible diagnosis of cardiac amyloidosis by * 1\. One of the fo...
Top 5 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Alnylam Pharmaceuticals, Inc | ALNY | 5 | PHASE3 | Vutrisiran, Nucresiran, patisiran |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 4 | PHASE3 | Coramitug |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Eplontersen, ALXN2220 |
| Intellia Therapeutics, Inc. | NTLA | 2 | PHASE3 | Nexiguran ziclumeran |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Eplontersen |
Florbetaben is a PET imaging agent used to detect or exclude cerebral beta-amyloid in patients being evaluated for Alzheimer disease. It has also been studied for diagnosing cardiac AL amyloidosis and for amyloid imaging in Down syndrome. It is given as an intravenous tracer before a positron emission tomography scan.
Florbetaben is developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker LNTH. The compound originated as BAY94-9172 and is now part of Lantheus's imaging portfolio.
Florbetaben has completed Phase 3 clinical development. Its trials are listed as completed, with no active studies ongoing, and the program includes both Phase 2 and Phase 3 imaging studies in Alzheimer disease, cardiac amyloidosis, and Down syndrome.
Completed trials include NCT05184088, a Phase 3 study of [18F]florbetaben PET for diagnosing cardiac AL amyloidosis; NCT01020838, a Phase 3 study comparing PET amyloid detection with histopathology; NCT01138111, a Phase 1 study in mild cognitive impairment; and NCT00928304, a Phase 2 study in Down syndrome.
Yes. Florbetaben is also known as BAY94-9172 and [18F]florbetaben. These names refer to the same fluorine-18 labeled small-molecule PET tracer, so literature and trial records using any of these names describe the same imaging agent.
Florbetaben binds cerebral beta-amyloid, the protein aggregate that accumulates in Alzheimer disease. As a fluorine-18 labeled small molecule, it crosses into the brain and its retention on PET imaging reflects amyloid burden, allowing detection or exclusion of amyloid plaques.