Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

Completed

• Conditions: Coronary Artery Disease; Aortic Aneurysm; Pulmonary Embolism

• Registration Number: NCT01272453
• Lead Sponsor: Gilbert L. Raff, MD

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2640

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiation dose	Time of CT scan	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

Name	Time	Method
Assessment of Image Quality	Time of CT Scan	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).

Trial Locations

Locations (9)

Naval Medical Center; 🇺🇸 San Diego, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

William Beaumont Hospital-Royal Oak; 🇺🇸 Royal Oak, Michigan, United States

William Beaumont Hospital-Troy; 🇺🇸 Troy, Michigan, United States

Minneapolis Heart Institute/ Abbott Northwestern; 🇺🇸 Minneapolis, Minnesota, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

King Abdul-Aziz Cardiac Center, national Guard Health Affairs; 🇸🇦 Riyadh, Kingdom of Saudi Arabia, Saudi Arabia