Skip to main content
OpenTrials
Completed

NCT Number: NCT01272453

Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Radiation dose

    Time frame: 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 outcomes

  1. Assessment of Image Quality

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Gilbert L. Raff, MD

Other

Collaborators

  • Siemens Healthcare Diagnostics Inc

Registry information

Official study title

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

Acronym: CTDOSE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2011
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.