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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-09-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PET with 18 F-Flutemetamol

PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication

Group Type EXPERIMENTAL

PET with 18 F-Flutemetamol

Intervention Type DRUG

PET with 18 F-Flutemetamol (Vizamyl ®)

Interventions

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PET with 18 F-Flutemetamol

PET with 18 F-Flutemetamol (Vizamyl ®)

Intervention Type DRUG

Other Intervention Names

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Vizamyl®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No