Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique (CTDOSE)
|ClinicalTrials.gov Identifier: NCT01272453|
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : May 30, 2014
|Condition or disease|
|Coronary Artery Disease Aortic Aneurysm Pulmonary Embolism|
The development of a novel CT scanner capable of sequential or fast-pitch spiral techniques in most patients (Siemens Definition Flash) represents a potentially crucial technical innovation at a particularly critical juncture. National healthcare systems are under pressure to deliver accurate and cost-effective diagnosis of an increasing number of patients and CT angiography in various settings is a proven, highly accurate technique that has been shown to improve diagnostic efficiency and reduce the cost of care.
However, there has been increasing concern about the lifetime attributable risk of cancer from radiation related to diagnostic procedures. Such concern extends to other radiation-based procedures that contribute to the cumulative lifetime radiation exposure of patients. The Flash scanner holds the promise of substantially reducing exposure resulting from a variety of examinations.
The CT DOSE multicenter trial is therefore designed to validate the extent of dose reduction attendant to the use of the Flash scanner in cardiothoracic scanning, and to determine whether image quality is preserved in spite of significant dose reduction.
|Study Type :||Observational|
|Actual Enrollment :||2640 participants|
|Observational Model:||Case Control|
|Official Title:||Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging|
|Study Start Date :||January 2011|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
Data from patients in the control group will be obtained retrospectively from patient medical records and stored image data
Prospective Patient Group
Data from patients in the Flash group will be obtained prospectively from scanner consoles and medical records.
- Radiation dose [ Time Frame: Time of CT scan ]The primary endpoint is radiation dose, measured as dose-length-product (DLP, in mGy∙cm) and effective radiation dose, calculated as DLP x 0.014 (in mSv).
- Assessment of Image Quality [ Time Frame: Time of CT Scan ]Signal noise (standard deviation of attenuation in Hounsfield units) will be determined in regions of interest in: A) air anterior to the chest wall, B) mid-LV septum and C) mid thoracic aorta or main PA. This will be done in a sequential sample of every 5th case (approximately 600 cases total).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272453
|United States, California|
|Naval Medical Center|
|San Diego, California, United States, 92134|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|William Beaumont Hospital-Royal Oak|
|Royal Oak, Michigan, United States, 48073|
|William Beaumont Hospital-Troy|
|Troy, Michigan, United States, 48085|
|United States, Minnesota|
|Minneapolis Heart Institute/ Abbott Northwestern|
|Minneapolis, Minnesota, United States, 55407|
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10006|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|King Abdul-Aziz Cardiac Center, national Guard Health Affairs|
|Riyadh, Kingdom of Saudi Arabia, Saudi Arabia, 11426|
|Principal Investigator:||Gilbert Raff, MD||William Beaumont Hospitals|