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Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries. (AMYLCAR)

T

Toulouse University Hospital

Status and phase

Terminated
Early Phase 1

Conditions

Cardiac Amyloidosis

Treatments

Drug: PET with 18 F-Flutemetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT03232632
13 199 02

Details and patient eligibility

About

To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

Full description

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

PET with 18 F-Flutemetamol
Experimental group
Description:
PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication
Treatment:
Drug: PET with 18 F-Flutemetamol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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