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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2011

Last Updated Date

September 26, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01272453 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

Official Title ^ICMJE

Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging

Brief Summary

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).

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Coronary Artery Disease
Aortic Aneurysm
Pulmonary Embolism

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

3000

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ann DePetris, RN, MSA

248.551.6683

ann.depetris@beaumont.edu

Location Countries ^ICMJE

United States, Saudi Arabia

Administrative Information

NCT Number ^ICMJE

NCT01272453

Other Study ID Numbers ^ICMJE

2010-209

Has Data Monitoring Committee

Responsible Party

Gilbert L. Raff, MD, William Beaumont Hospitals

Study Sponsor ^ICMJE

Gilbert L. Raff, MD

Collaborators ^ICMJE

Siemens Healthcare Diagnostics Inc

Investigators ^ICMJE

Principal Investigator:

Gilbert Raff, MD

William Beaumont Hospitals

Information Provided By

William Beaumont Hospitals

Verification Date

September 2012

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

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