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  1. Medical X-ray Imaging

Other Information Resources Related to Whole-Body CT Screening

This page contains a listing of links and other references that provide additional information related to computed tomography and the use of it for screening. Topics are listed under the following headings:

Readers are cautioned that many of these links are to sources of information external to the FDA web site and present information that has not been verified or endorsed by the FDA. Provision of such a link or information should not be considered an endorsement by the FDA or the Department of Health and Human Services of the information on these pages.

General information

New England Journal of Medicine (NEJM) Article, November 29, 2007
"Computed Tomography (CT) - An Increasing Source of Radiation Exposure"
[Text] http://content.nejm.org/cgi/content/full/357/22/2277

Brochure: Full-Body CT Scans: What You Need to Know

A Dictionary of Cancer Terms from the National Cancer Institute.
http://www.cancer.gov/dictionary/

Information from the National Cancer Institute on Testing for Cancer.
https://www.cancer.gov/about-cancer/screening/screening-tests
 
A list of abbreviations related to CT from a web site specializing in CT evaluations.
http://www.impactscan.org/abbreviations.htm

A public information web site sponsored by the Radiological Society of North America and the American College of Radiology describing computed tomography of the body.
http://www.radiologyinfo.org/content/ct_of_the_body.htm

A general discussion of the diagnostic uses of CT, why it is used, how it works and what to expect during an examination.
http://www.imaginis.com/ct-scan/

A list of links to Computed Tomography (CT) web sites.
 
Link to information regarding radiation and its effects.
https://www.epa.gov/radiation/radiation-health-effects

Information on screening

A recent opinion article in a leading radiology journal that raises concerns about the use of radiologic screening procedures in general.
http://www.ajronline.org/cgi/content/full/177/5/989

Article from the June 2001 issue of the American Journal of Roentgenology entitled "Ten Criteria for Effective Screening: Their Application to Multislice CT Screening for Pulmonary and Colorectal Cancer". This article describes ten criteria for an effective screening program in terms of the characteristics of the disease, the characteristics of the screening test and the treatments available if disease is found. http://www.ajronline.org/cgi/content/full/176/6/1357

An article from the American Medical Association's American Medical News (Sept. 3, 2001) discussing "Full-body scans: Buying peace of mind."
http://www.ama-assn.org/sci-pubs/amnews/pick_01/hlsa0903.htm

Web site operated by the National Cancer Institute that provides general information on cancer and related issues.
http://cancer.gov/

The following section of the above web site provides a Cancer Screening Overview.
https://www.cancer.gov/about-cancer/screening/patient-screening-overview-pdq

Clinical studies

There are a number of studies that have been conducted or are underway to evaluate the effectiveness or benefit of the use of CT in screening for specific disease conditions in specific high-risk populations. Among these are studies of CT to screen for coronary artery disease, colon cancer, and lung cancer. Examples of these studies are the following that are being sponsored by the American College of Radiology Imaging Network:

Radiation risks

The National Council on Radiation Protection and Measurements (NCRP) is a nonprofit organization chartered by Congress that makes recommendations regarding protection against radiation. Several recent reports from the NCRP (http://www.ncrp.com) are relevant to the question of the risk from medical x-ray procedures.

  • NCRP Report No. 115, Risk Estimates for Radiation Protection (1993).
  • NCRP Report No. 126, Uncertainties in Fatal Cancer Risk Estimates Used in Radiation Protection (1997).
  • NCRP Report No. 136, Evaluation of the Linear-Nonthreshold Dose-Response Model for ionizing Radiation (2001).

The most recent evaluation of the effects of ionizing radiation by the National Academy of Sciences is given in the following publication:

The most recent report from the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) is contained in the following two volumes available from UNSCEAR.

SOURCES AND EFFECTS OF IONIZING RADIATION
United Nations Scientific Committee on the Effects of Atomic Radiation.
UNSCEAR 2000 Report to the General Assembly,
with scientific annexes Volume I: SOURCES.
http://www.unscear.org/unscear/en/publications/2000_1.html

SOURCES AND EFFECTS OF IONIZING RADIATION
United Nations Scientific Committee on the Effects of Atomic Radiation.
UNSCEAR 2000 Report to the General Assembly,
with scientific annexes Volume II: EFFECTS.
http://www.unscear.org/unscear/en/publications/2000_2.html

The most recent statement of the U. S. Government about estimating the risk from ionizing radiation is given in the following publication:

  • Marvin Rosenstein, et al. (CIRRPC Panel Report No. 9), Use of BEIR V and UNSCEAR 1988 in Radiation Risk Assessment. Lifetime Total Cancer Mortality and Risk Estimates at Low Doses and Low Dose Rates for Low-LET Radiation, Committee on Interagency Radiation Research and Policy Coordination, Office of Science and Technology Policy, Executive Office of the President, Washington, D.C, December 1992.

The following links describe recent results on the risk from ionizing radiation from the evaluation of data from the study of atomic bomb survivors from the Radiation Effects Research Foundation (RERF).

Radiation dose from CT procedures

Information on typical radiation effective doses from diagnostic procedures.
European Commission, Radiation Protection Report 118, "Referral guidelines for imaging." Directorate-General for the Environment of the European Commission, 2000.

Information on a recent publication from the European Coordination Committee of the Radiological and Electromedical Industries (COCIR) describing radiation exposure in computed tomography.

CT dose information from the ImPACT Group in the United Kingdom sponsored by the Medical Devices Agency.

Discussion of dosimetry concepts used in computed tomography from a European Commission publication "EUROPEAN GUIDELINES ON QUALITY CRITERIA FOR COMPUTED TOMOGRAPHY."
http://www.drs.dk/guidelines/ct/quality/Page032.htm

Preliminary data from FDA's Nationwide Evaluation of X-Ray Trends (NEXT) 2000-01 Survey of Patient Radiation Exposure from Computed Tomographic (CT) Examinations in the United States.
PowerPoint

Final Results: Nationwide Evaluation of X-Ray Trends (NEXT) - Tabulation and Graphical Summary of 2000 Survey of Computed Tomography

Brochure: Radiation risks and Pediatric Computed Tomography (CT): A Guide for Health Care Providers

Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients

FDA's regulatory program for CT

Food, Drug, and Cosmetic Act

Performance standard for diagnostic x-ray systems
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=1020.30

Medical Device regulations

Premarket Notification 510(k) guidance document

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