Radiation Dose From Computed Tomography Before and After Implementation of a High Pitch Dual Spiral Technique (FLASH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Gallagher, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01111760
First received: April 26, 2010
Last updated: April 3, 2013
Last verified: April 2013

April 26, 2010
April 3, 2013
May 2010
December 2012   (final data collection date for primary outcome measure)
Comparison of the radiation dose for chest CT examinations using current technology with radiation dose exposure using the newest generation CT scanner. [ Time Frame: Time of CT scan ] [ Designated as safety issue: Yes ]
The primary objective of this study is to compare the estimated radiation dose for chest CT examinations (cardiac and non cardiac) performed using current technology (ie. Retrospective gated CT examinations on the 64 slice and dual source Definition Siemens CT scanners) with the radiation exposure using the newest generation CT scanner (high pitch dual source spiral technique).
Same as current
Complete list of historical versions of study NCT01111760 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Radiation Dose From Computed Tomography Before and After Implementation of a High Pitch Dual Spiral Technique
Radiation Dose From Computed Tomography Before and After Implementation of a High Pitch Dual Spiral Technique

The purpose of this study is to compare the radiation exposure of a variety of chest CT examinations performed on the current state of the art CT scanners (64 slice, dual source CT scanner) with the radiation exposure for identical chest CT examinations performed on the Siemens Flash CT scanner (high pitch dual source spiral technique).

Computed tomography has emerged as the "gold standard" for the diagnosis of a broad range of medical diagnoses. For cardiac imaging alone, the installation of CT scanners in US cardiology practices alone has tripled over the past 2 years. Patients who undergo cardiac CTA (computed tomography angiography) may be subjected to relatively high doses of ionizing radiation (ie. 4 times annual background radiation) during the diagnosis and management of coronary artery disease. Current radiation doses for cardiac CT examinations are comparable to the effective doses for patients undergoing nuclear stress tests or cardiac catheterization (ie. approximately 10-15 milliSieverts). In addition, non cardiac CT protocols, such as chest CT examinations for the evaluation of pulmonary arteries, thoracic and abdominal aorta, and lung nodules, are associated with significant radiation exposure. Many patients undergo repeated CT examinations over several years for such pathology. There is a growing public concern regarding the cancer risk associated with such radiation.

Recent major technological advances have been made with the advent of newer generation CT scanners which allow significant radiation dose reduction. One such scanner, the dual source CT, is a new high pitch dual source spiral technique that offers the ability to image a patient's chest with ECG gated imaging protocols within a single second. These technological advances allow significant radiation dose savings, often resulting in effective radiation doses of less than one millisievert (mSv).

Observational
Observational Model: Case-Only
Not Provided
Not Provided
Probability Sample

any patient receiving a coronary CT scan and a chest CT for pulmonary embolisms, pulmonary nodules, aortic pathologies

  • Atherosclerosis of Coronary Artery
  • Cardiovascular Disease
  • Pulmonary Embolism
  • Aortic Aneurysm Without Mention of Rupture Nos
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
February 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients who undergo chest CT examinations (including cardiac CTA, and non cardiac CT examinations including pulmonary embolism, lung nodule and aortic pathology protocols)
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01111760
HIC 2010-082
No
Michael Gallagher, William Beaumont Hospitals
Michael Gallagher
Not Provided
Principal Investigator: Michael Gallagher, MD William Beaumont Hospitals
Study Director: Gilbert Raff, MD William Beaumont Hospitals
William Beaumont Hospitals
April 2013

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