Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.
| Registry | NCT03232632, acronym AMYLCAR |
|---|---|
| Status | Terminated - intervention programming |
| Phase | Early Phase 1 |
| Study type | Interventional; na, single group, masking: none, supportive care |
| Enrollment | 7 (Actual) |
| Sponsor | University Hospital, Toulouse (Other) |
| Conditions | Cardiac Amyloidosis |
| Interventions | PET with 18 F-Flutemetamol (Drug) |
| Dates | start 2017-03-15, primary completion 2019-09-15, completion 2019-09-15, first posted 2017-07-28, last updated 2020-08-26 |
| Locations | 1 site in France |
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To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.
Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease.
Because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries.
Results of this PET will be combined with scan examinations for a better anatomic tracking.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PET with 18 F-Flutemetamol | Experimental | Drug: PET with 18 F-Flutemetamol | PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients followed for amyloidosis with proved cardiac injury or strongly suspected: * cardiac echography with typical signs of amyloid injury, * anatomical result confirming presence of amyloid deposits at cardiac or peripheral level * Signature of Informed Consent Form, * Affiliation to a social security system Exclusion Criteria: * Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit), * Pregnancy and lactating women, * Absence of effective contraception, * Irradiating examination performed within the last 12 months or scheduled within the next 12 months, * Unable patient physically, mentally or legally to provide informed consent, * Patient under a system of legal protection
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital Toulouse | Toulouse | France |