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

Early Phase 1

Terminated

• Conditions: Cardiac Amyloidosis
• Interventions: Drug: PET with 18 F-Flutemetamol

• Registration Number: NCT03232632
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-11
• Study Start: 2017-03-15
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-28
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) measures	average of last 15 minutes	standardized uptake value (SUV) measures
ratio Heart/ Upper Mediastinum	average of last 15 minutes	peak of 18F-Flutemetamol capture

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France