Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01272453

Acronym

CTDOSE

Enrollment

2640

Registered

2011-01-07

Start date

2011-01-31

Completion date

2013-10-31

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Coronary Artery Disease, Pulmonary Embolism

Keywords

coronary artery disease, CT scan, coronary angiography, chest pain, aortic aneurysm, pulmonary embolism

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Saudi Arabia, United States

Outcome results