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Florbetaben PET for Cardiac Amyloidosis (CArdiag Trial)

Phase 3

Recruiting

Research Sponsored by Life Molecular Imaging GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 17 days after imaging visit

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will use a type of imaging called PET scans to look at the hearts of patients who might have a specific heart condition.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

Potential side effects from [18F]florbetaben include reactions at the injection site, such as pain or irritation, as well as rare allergic reactions. The PET scan itself is non-invasive but involves exposure to a small amount of radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 17 days after imaging visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 17 days after imaging visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 days after imaging visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.

Secondary study objectives

Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.

Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).

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.

+2 more

Other study objectives

Sensitivity and specificity of [18F]florbetaben PET images for a differential diagnosis between AL CA, ATTR CA and non CA will be assessed.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]florbetaben

2016

Completed Early Phase 1

~30

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