Hybrid 18F-Florbetaben PET/MRI to image cardiac amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational imaging study using hybrid 18F-Florbetaben PET/MRI in patients with proven cardiac amyloidosis (ATTR or AL). Participants will undergo PET/MR imaging with PET markers from Florbetaben and cardiac MRI sequences including LGE, ECV, and native T1 mapping, with echocardiography measures (EF, strain, E/e') also recorded. The study will compare individual imaging parameters between modalities and stratify clinical outcomes by PET-derived parameters. The primary clinical endpoint is occurrence of major adverse cardiac events (MACE) such as heart failure hospitalizations, cardiovascular death, or device implantation, recorded during follow-up at the University Hospital Essen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 40 years
* proven Amyloidosis (ATTR or AL)
* Women: negative pregnancy test less than weeks prior imaging.

Exclusion Criteria:

* Patients receiving amyloidosis-specific treatment prior study inclusion.
* Patients participating in other clinical trails for treatment of Amyloidosis.
* Pregnancy
* Contraindiactions for MRI (eGFR\<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for 3T MRI).
* inability of consent
* Refusal of consent

Where it's running

• Department of Nuclear medicine, University Hospital Essen
  Essen, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: David Kersting, MD, PhD
• Email: david.kersting@uk-essen.de
• Phone: +492017232073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.