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

Cardiovascular Disease Clinical Trial

— FLASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111760
• Other study ID #: HIC 2010-082
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: April 3, 2013
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm Without Mention of Rupture Nos
• Atherosclerosis
• Atherosclerosis of Coronary Artery
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Embolism
• Myocardial Ischemia
• Pulmonary Embolism

Locations

Country	Name	City	State
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michael Gallagher

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the radiation dose for chest CT examinations using current technology with radiation dose exposure using the newest generation CT scanner.	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).	Time of CT scan	Yes