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
  Purpose

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).


Condition
Atherosclerosis of Coronary Artery
Cardiovascular Disease
Pulmonary Embolism
Aortic Aneurysm Without Mention of Rupture Nos

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Radiation Dose From Computed Tomography Before and After Implementation of a High Pitch Dual Spiral Technique

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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).


Enrollment: 334
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01111760

Locations
United States, Michigan
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Michael Gallagher
Investigators
Principal Investigator: Michael Gallagher, MD William Beaumont Hospitals
Study Director: Gilbert Raff, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Michael Gallagher, Cardiologist, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01111760     History of Changes
Other Study ID Numbers: HIC 2010-082
Study First Received: April 26, 2010
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
cardiovascular disease
heart CT scan
CT scan
pulmonary embolisms
aortography

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Atherosclerosis
Cardiovascular Diseases
Embolism
Pulmonary Embolism
Rupture
Vascular Diseases
Aortic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014