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

This study has been completed.
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: May 29, 2014
Last verified: May 2014
  Purpose

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).


Condition
Coronary Artery Disease
Aortic Aneurysm
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 2640
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272453

Locations
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
Saudi Arabia
King Abdul-Aziz Cardiac Center, national Guard Health Affairs
Riyadh, Kingdom of Saudi Arabia, Saudi Arabia, 11426
Sponsors and Collaborators
Gilbert L. Raff, MD
Siemens Healthcare Diagnostics Inc
Investigators
Principal Investigator: Gilbert Raff, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Gilbert L. Raff, MD, Medical Director, Advanced Cardiovascular Imaging, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01272453     History of Changes
Other Study ID Numbers: 2010-209
Study First Received: January 6, 2011
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
coronary artery disease
CT scan
coronary angiography
chest pain
aortic aneurysm
pulmonary embolism

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Embolism
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014