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Florbetaben F18

Phase 1

Cardiac Amyloidosis | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Aug 3, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

Florbetaben F18 · 1 trial · 1 indication

Phase 1 1
NCT06790394Test-retest Study With [18F]FBB in Cardiac AmyloidosisCardiac Amyloidosis
RECRUITING15 Analytics
PHASE1RECRUITING
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
Cardiac AmyloidosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Test-Retest variability of cardiac [18F]florbetaben PET uptake
The duration of the study for participants may be up to 73 days.

Percent Test-Retest variability (%) of cardiac 18F florbetaben PET

Secondary Endpoints

Test-Retest variability of extracardiac [18F]florbetaben uptake
The duration of the study for participants may be up to 73 days.
Net influx rate derived from full tracer kinetic modelling
The duration of the study for participants may be up to 73 days.
Volume of distribution derived from full tracer kinetic modelling
The duration of the study for participants may be up to 73 days.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Patients with cardiac diseaseEXPERIMENTALAll eligible AL, ATTR and non-CA patients will receive two injections of the investigational imaging agent florbetaben: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 patients of each group will be required.

Interventions

NameTypeDescription
Florbetaben F18DRUGFlorbetaben F18 is a radioactive diagnostic agent being developed for the indication of PET imaging of the heart to detect amyloid pathology. All patients will receive two administrations of Florbetaben F18 at a radioactive dose of 300 megabecquerel (MBq).
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Inclusion criteria (for all subjects): * Males and females aged ≥40 years * Able to understand, sign, and date written informed consent * Written informed consent must be obtained before any assessment is performed * Female subjects must be documented by medical recor...

Countries:United Kingdom
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT06790394lastUpdatePostDate: changed

Frequently asked questions about Florbetaben F18

What is Florbetaben F18 used for in Cardiac Amyloidosis?

Florbetaben F18 is an investigational small molecule being studied for use in Cardiac Amyloidosis, a condition where abnormal protein deposits accumulate in the heart. It is currently in Phase 1 clinical development, with an active trial evaluating its test-retest reliability as an imaging agent for this disease.

What does Florbetaben F18 target?

Florbetaben F18 is a radioactive tracer that binds to amyloid deposits, which are abnormal protein aggregates that accumulate in tissues. In the context of Cardiac Amyloidosis, it is designed to detect these deposits in the heart, potentially aiding in diagnosis and monitoring of the condition.

Who makes Florbetaben F18?

Florbetaben F18 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting a Phase 1 clinical trial to evaluate the agent's performance in patients with Cardiac Amyloidosis.

What phase is Florbetaben F18 in?

Florbetaben F18 is in Phase 1 clinical development. It is an investigational agent, not yet approved by regulatory authorities, and is currently being studied in a single active trial for Cardiac Amyloidosis. The trial is recruiting participants in the United Kingdom.

What clinical trials is Florbetaben F18 in?

Florbetaben F18 is being evaluated in a Phase 1 clinical trial with the identifier NCT06790394, titled 'Test-retest Study With [18F]FBB in Cardiac Amyloidosis.' This single-arm, uncontrolled study is recruiting 15 participants aged 40 years and older in the United Kingdom.

Is Florbetaben F18 the same as [18F]FBB?

Yes, Florbetaben F18 is also known as [18F]FBB, as indicated by the clinical trial title. The compound is a fluorine-18 labeled tracer, and the abbreviation FBB refers to florbetaben, the active pharmaceutical ingredient.