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

Cardiac Amyloidosis Clinical Trial

— AMYLCAR  

Official title:

Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03232632
• Other study ID #: 13 199 02
• Status: Terminated
• Phase: Early Phase 1
• Start date: March 15, 2017
• Est. completion date: September 15, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Drug:
• PET with 18 F-Flutemetamol
PET with 18 F-Flutemetamol (Vizamyl ®)

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ratio Heart/ Upper Mediastinum	peak of 18F-Flutemetamol capture	average of last 15 minutes
Primary	standardized uptake value (SUV) measures	standardized uptake value (SUV) measures	average of last 15 minutes