Health TrialsbyHealthPanel

Hybrid Florbetaben PET/MRI for Imaging of Cardiac Amyloidosis

ConditionCardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity Hospital, Essen

About this trial

Exploration of prognostic parameters in 18F-Florbetaben PET/MRI in patients with cardiac amyloidosis. The clinical endpoints are defined as occurence of major adverse cardiac events (MACE) in amyloidosis patients. Additionally, MACE outcome stratified by PET parameters will be evaluated and individual parameters of the imaging techniques will be compared to each other (PET, MRI or echocardiography).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 40 years

proven Amyloidosis (ATTR or AL)

Women: negative pregnancy test less than weeks prior imaging.

Disqualifiers

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).

Trial population

Patients with proven amyloidosis with no competing amyloidosis treatments, willing and capable of undergoing Florbetaben PET/MRI.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

25 Participants
are grouped into 1 trial group
Group A: Amyloidosis

Trial outcomes

Primary outcomes

1

Occurence of MACE

Occurence of MACE, MACE defined as All-cause of Death or Hospitalization due to heart failure, implantation of a cardioverter defibrillator or other urgent cardiovascular intervention.

Time frame
36 Months

Secondary outcomes

1

MACE free survival by optimal tracer retention index for MACE

MACE free survival by optimal tracer retention index (RI), threshold defined by ROC analysis for prediction of MACE.

Time frame
36 Months
2

MACE free survival by optimal SUV threshold for MACE

MACE free survival by optimal standardized uptake value (SUV), threshold defined by ROC analysis for prediction of MACE.

Time frame
36 Months
3

MACE free survival by optimal retention index for AL-Amyloidosis

MACE free survival by optimal SUV, threshold defined by ROC analysis for prediction of AL-Amyloidosis.

Time frame
36 Months
4

MACE free survival by optimal PET based threshold for AL-Amyloidosis

MACE free survival by optimal tracer retention index (RI) defined by ROC analysis for prediction of AL-Amyloidosis.

Time frame
36 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

Source ClinicalTrials.gov
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