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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500186-27-00

Acronym

FBB-02-01-21a

Enrollment

169

Registered

2022-08-24

Start date

2023-01-11

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ATTR Amyloidosis, Cardiac Amyloidosis, AL Amyloidosis

Brief summary

The co-primary efficacy variables will be the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis

Detailed description

The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis, Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass), Correlation of quantitative [18F]florbetaben PET results with AL-CA prognostic values (Mayo stage I – IV) based on FLC-diff, cTnT and NT-proBNP levels., The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician’s questionnaires before and after the diagnostic work-up, and after receipt of the PET results

Interventions

DRUGNeuraceq 300 MBq/mL solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The co-primary efficacy variables will be the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis	—

Secondary

Measure	Time frame
The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis, Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass), Correlation of quantitative [18F]florbetaben PET results with AL-CA prognostic values (Mayo stage I – IV) based on FLC-diff, cTnT and NT-proBNP levels., The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician’s questionnaires before and after the diagnostic work-up, and after receipt of the PET results	—

Measure

Time frame

—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026