Hybrid 18F-Florbetaben PET/MRI to image cardiac amyloidosis
Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With Cardiac Amyloidosis
This trial will test whether a combined 18F-Florbetaben PET and MRI scan can find imaging signs that predict major heart events in people with cardiac amyloidosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 1 site (Essen, North Rhine-Westphalia) |
| Trial ID | NCT07154381 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 40 with proven ATTR or AL cardiac amyloidosis who are not yet receiving amyloidosis-specific therapy and who can safely undergo 3T MRI and give informed consent.
Not a fit: Patients already on amyloidosis-specific treatment, those with contraindications to MRI (severe renal impairment, incompatible implants, gadolinium allergy), pregnant individuals, or those unable/unwilling to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help identify patients at higher risk of major cardiac events so clinicians can personalize monitoring and treatment.
How similar studies have performed: Previous PET studies using beta-amyloid tracers have shown promise for detecting cardiac amyloid and suggesting prognostic signals, but using hybrid PET/MRI specifically for prognostic stratification remains relatively novel and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Essen, North Rhine-Westphalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.