18F-deoxyglucose (FDG) PET-CMD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02078141|
Recruitment Status : Unknown
Verified March 2018 by Nantes University Hospital.
Recruitment status was: Active, not recruiting
First Posted : March 5, 2014
Last Update Posted : March 30, 2018
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a promising tool for identification of myocardial inflammation in patients with dilated cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the frequency and describe the different binding profiles in comparison with MRI data.
Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.
All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A high fat and low carbohydrate diet and an heparin injection will be prescribed to patients before this FDG PET.
Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be completed by a 12 months evaluation.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Idiopathic Dilated Cardiomyopathy||Drug: 18F-deoxyglucose (FDG)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||May 2018|
- Drug: 18F-deoxyglucose (FDG)
18F-deoxyglucose (FDG) One injection of 3.5 MBq/kg of 18FDG with a minimum of 220 MBq and a maximum of 400 MBq
- Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism [ Time Frame: 12 months ]We want to objective a significant hypermetabolic extra-cardiomyocyte by 18F-FDG PET examination, in favor of myocardial inflammation in patients with DCM diagnosed for more than two weeks without new ventricular arrhythmias or second AVB or third degree, and who responded to the usual treatment in the first two weeks of treatment.
- Comparison of clinical, biology, and left and ventricular remodeling at the time of diagnosis of DCM between the group of patients with significative myocardial no cardiomyocytaire uptake (FDG +) and those with no uptake (FDG -) [ Time Frame: 12 months ]
- Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI [ Time Frame: 12 months ]
- Describe the different profile of FDG fixation within the group of patients FDG + [ Time Frame: 12 months ]
- impact of the presence or absence of a non-cardiomyocyte uptake of 18F-FDG PET at diagnosis of DCM in regard to the clinical status, ultrasound and MRI results [ Time Frame: 12 months ]
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): NCT02078141
|Nantes, France, 44903|
|West Cancerology Institute/Nantes UH : PET plateform|
|Saint Herblain, France, 44805|
|Principal Investigator:||Nicolas Piriou, MD||Nantes UH|