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

August 24, 2020 updated by: University Hospital, Toulouse

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET with 18 F-Flutemetamol
PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication
Drug: PET with 18 F-Flutemetamol
PET with 18 F-Flutemetamol (Vizamyl ®)
Other Names:
  • Vizamyl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ratio Heart/ Upper Mediastinum
Time Frame: average of last 15 minutes
peak of 18F-Flutemetamol capture
average of last 15 minutes
standardized uptake value (SUV) measures
Time Frame: average of last 15 minutes
standardized uptake value (SUV) measures
average of last 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Eric OUHAYOUN, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

September 15, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 199 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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