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
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Amyloidosis||Drug: PET with 18 F-Flutemetamol||Early Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||7 participants|
|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|
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®
- ratio Heart/ Upper Mediastinum [ Time Frame: average of last 15 minutes ]peak of 18F-Flutemetamol capture
- standardized uptake value (SUV) measures [ Time Frame: average of last 15 minutes ]standardized uptake value (SUV) measures
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
|University Hospital Toulouse|
|Toulouse, France, 31000|
|Principal Investigator:||Eric OUHAYOUN, MD||University Hospital, Toulouse|