Back to resultsAssessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries. (AMYLCAR)
Primary Purpose
Cardiac Amyloidosis
Status
Terminated
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
PET with 18 F-Flutemetamol
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiac Amyloidosis
Eligibility Criteria
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
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET with 18 F-Flutemetamol
Arm Description
PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication
Outcomes
Primary Outcome Measures
ratio Heart/ Upper Mediastinum
peak of 18F-Flutemetamol capture
standardized uptake value (SUV) measures
standardized uptake value (SUV) measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03232632
First Posted
January 11, 2017
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03232632
Brief Title
Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.
Acronym
AMYLCAR
Official Title
Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
intervention programming
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET with 18 F-Flutemetamol
Arm Type
Experimental
Arm Description
PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication
Intervention Type
Drug
Intervention Name(s)
PET with 18 F-Flutemetamol
Other Intervention Name(s)
Vizamyl®
Intervention Description
PET with 18 F-Flutemetamol (Vizamyl ®)
Primary Outcome Measure Information:
Title
ratio Heart/ Upper Mediastinum
Description
peak of 18F-Flutemetamol capture
Time Frame
average of last 15 minutes
Title
standardized uptake value (SUV) measures
Description
standardized uptake value (SUV) measures
Time Frame
average of last 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric OUHAYOUN, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.
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