Canadian Fluoroscopy Cohort Study (CFCS)

Study collaborators and Members of the CFCS Advisory Board at the first meeting of the CFCS Advisory Board in San Francisco on November, 7-8, 2016. Left to Right (Dr. John McLaughlin, Dr. Paul Villeneuve, Dr. Lydia Zablotska, Dr. John Miller, Dr. Iulian Apostoaei and Dr. Hoffman).

A researcher in the 1890s examines his hand with a fluoroscope.
Fluoroscopy in the 1890s
Posterior-anterior fluoroscopy.
The King Edward Sanatorium
The King Edward Sanatorium opened in 1907 at Tranquille, BC. In 1905, the first sanatoriums were approved by the Canadian government.
Thomas Edison
Thomas Edison examines the hand of Clarence Dally, his assistant, through a fluoroscope of his own design. Thomas Edison worked on early commercial models in the 1890s.

The proposed update of the Canadian Fluoroscopy Cohort Study (CFCS) will address critical gaps in knowledge of the long-term health risks of protracted radiation exposures from diagnostic imaging procedures. The rise of computerized X-ray tomography (CT) is remarkable with well over 85 million examinations per year performed in the United States alone. The causal association between high doses of gamma radiation and increased risks of cancer are firmly established, but the risks of low-dose X-ray radiation exposures protracted over a period of time remain undetermined.

Current radiation safety standards for CT scans are based in large part on the study of Japanese atomic bomb (A-bomb) survivors exposed in 1945 to instantaneous high- energy gamma radiation. National and international radiation protection agencies recommend reducing estimates of excess risks from CT scans projected from the A-bomb data by a factor of 1.5-2.0, although recent studies of occupationally exposed workers show similar risks per unit of radiation dose irrespective of the dose protraction. Thus, potentially, these risk projection could underestimate cancer risks by 150-200%. Recently published studies reporting significantly increased risks of leukemia after multiple CT scans in children have raised concerns because of the absence of individual dosimetry and the possibility of confounding by indication or reverse causation. The risks in adults and the risks of lung and breast cancer, the most frequent cancers in the U.S. population, remain undetermined.

To provide clarity and to address important gaps in our knowledge, we propose to extend the mortality follow-up of the 63,707 CFCS patients exposed to repeated diagnostic imaging fluoroscopies in 1930-1952 by additional 30 years (for a total of 68 years, 1950-2017) as well as to conduct for the first time incidence follow-up (1969-2017). We will use CFCS's large size, the long follow-up, the individual dose assessments and the similarities in radiation exposures between fluoroscopies and CT scans to gain an unprecedented opportunity to conduct a life course examination of radiation risks. To achieve CFCS aims, we will develop a new Fluoroscopy X-rays Organ- Specific (FLUXOR) Dosimetry System and link the cohort to the Canadian Mortality and Incidence Databases covering the entire population of Canada. In addition to radiation doses to multiple organs, we will have unique data on modifiable risk factors, such as smoking, to evaluate multi-factorial etiology of cancer outcomes. Applicability of radiation risks estimated in the cohort to the U.S. general population will be further examined by pooling the CFCS data with the data from the Massachusetts Fluoroscopy Cohort Study (n=13,385). The efficient study design will provide important and previously unavailable scientific evidence on the lifespan risks of protracted radiation exposures. The research team includes experts in radiation epidemiology, biostatistics and dosimetry and is uniquely qualified to assess the appropriateness of current radiation safety standards for diagnostic imaging procedures, in particular for CT scans.

Public Health Relevance

The proposed analysis of lifespan mortality and cancer risks in the Canadian Fluoroscopy Cohort Study (CFCS) will address critical gaps in our knowledge of the long-term health risks of protracted radiation exposures from computed tomography (CT) scans, the area of public health interest and concern. This large study of 63,707 Canadian tuberculosis patients exposed to diagnostic imaging fluoroscopies over an extended period of time is designed to quantify lifespan risks of lung and breast cancer and leukemia associated with low doses of ionizing radiation. CFCS findings will help determine appropriateness of current radiation safety standards based on the risk projections from the study of survivors of atomic bombings in Japan.

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