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Patients with suspected cardiac amyloidosis for 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

CArdiag 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.Check my eligibility

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.See study design

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.

CArdiag Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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

CArdiag 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Life Molecular Imaging GmbHLead Sponsor

4 Previous Clinical Trials

1,312 Total Patients Enrolled

pharmtrace klinische Entwicklung GmbHUNKNOWN

1 Previous Clinical Trials

18 Total Patients Enrolled

Andrew Stephens, MD, PhDStudy DirectorLife Molecular Imaging

4 Previous Clinical Trials

255 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase for this investigation currently ongoing?

"As per clinicaltrials.gov, patient enrollment is currently ongoing for this investigation. The study was initially released on January 13th, 2023 and its most recent update was made on April 11th, 2024."

Answered by AI

At how many distinct sites is this clinical trial being overseen?

"At the moment, enrollment for this research is ongoing at 14 different locations. These sites are situated in various cities such as Berlin, Augsburg, and Essen among others. Opting for a site near your residence can help reduce travel-related challenges when taking part in the study."

Answered by AI

What is the upper limit of participants involved in this research endeavor?

"Yes, the details on clinicaltrials.gov state that this trial is actively enrolling participants. The study was first listed on January 13th, 2023, and last revised on April 11th, 2024. They aim to recruit a total of 200 individuals from 14 different locations."

Answered by AI

Has the FDA granted approval for patients suspected of having cardiac amyloidosis?

"Our team at Power has rated the safety of patients with suspected cardiac amyloidosis as 3 on our scale, as this trial is in Phase 3. This suggests that there exists preliminary effectiveness data alongside extensive safety information."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

2023. "Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05184088.

All > Al Amyloidosis > Amyloidosis