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

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ClinicalTrials.gov Identifier: NCT03232632
Recruitment Status : Terminated (intervention programming)
First Posted : July 28, 2017
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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

Condition or disease Intervention/treatment Phase
Cardiac Amyloidosis Drug: PET with 18 F-Flutemetamol Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

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 Name: Vizamyl®




Primary Outcome Measures :
  1. ratio Heart/ Upper Mediastinum [ Time Frame: average of last 15 minutes ]
    peak of 18F-Flutemetamol capture

  2. standardized uptake value (SUV) measures [ Time Frame: average of last 15 minutes ]
    standardized uptake value (SUV) measures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232632


Locations
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France
University Hospital Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Eric OUHAYOUN, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03232632    
Other Study ID Numbers: 13 199 02
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action