Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique (CT DOSE)

This study is currently recruiting participants.
Verified September 2012 by William Beaumont Hospitals
Sponsor:
Collaborator:
Siemens Healthcare Diagnostics Inc
Information provided by (Responsible Party):
Gilbert L. Raff, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01272453
First received: January 6, 2011
Last updated: September 26, 2012
Last verified: September 2012

January 6, 2011
September 26, 2012
January 2011
June 2013   (final data collection date for primary outcome measure)
Radiation dose [ Time Frame: Time of CT scan ] [ Designated as safety issue: Yes ]
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).
Same as current
Complete list of historical versions of study NCT01272453 on ClinicalTrials.gov Archive Site
Assessment of Image Quality [ Time Frame: Time of CT Scan ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique
Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging

This is a prospective, controlled observational trial of patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA).

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA)at 10 sites. Patient selection will be based on a site consecutive CT scan log.

  • Coronary Artery Disease
  • Aortic Aneurysm
  • Pulmonary Embolism
Not Provided
  • Control Group
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scans from patients undergoing clinically indicated pulmonary angiography, aortography and/or CCTA.
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • No exclusions
Both
18 Years and older
No
Contact: Ann DePetris, RN, MSA 248.551.6683 ann.depetris@beaumont.edu
United States,   Saudi Arabia
 
NCT01272453
2010-209
No
Gilbert L. Raff, MD, William Beaumont Hospitals
Gilbert L. Raff, MD
Siemens Healthcare Diagnostics Inc
Principal Investigator: Gilbert Raff, MD William Beaumont Hospitals
William Beaumont Hospitals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP