Clinical trial NCT02911155: Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Official title: Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Cancer
Thyroid Cancer
Circulatory Disease
Breast Cancer
Keywords: Cohort Study
Radiation
Occupation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2016-09-22
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an occupational cohort of 35,593 U.S. nuclear medicine technologists certified by the American Registry of Radiologic Technologist or the Nuclear Medicine Technology Certification Board in 1980 or later.

Brief summary: Background:

The field of nuclear medicine has changed a lot in the past decades. Technology has gotten better, so patients are exposed to less radiation. But now workers are doing procedures more often and using lead aprons less. So they may be exposed to more radiation. This may put them at higher risk for cancers and other health problems that are related to radiation. Researchers want to collect data from technologists to learn more about the risks and appropriate doses of radiation.

Objective:

To learn more about the risks and appropriate doses of radiation for nuclear medicine technologists.

Eligibility:

Adults who were first certified in nuclear medicine technology in the United States after 1980. They must be living in the United States. They must not be participants in the USRT study.

Design:

Participants will be recruited online.

Participants will complete an online survey. It will take about a half hour. This will have questions about their work with nuclear medicine procedures. There will be questions about the kinds of procedures and how often they do them.

Participants will give a short work history. This will include the names of current and past employers.

Participants will allow researchers to get records of their film badge dose readings. These will come from dosimetry providers.

Dosimetry data will not be shared with participants. Researchers can t ensure the how accurate or complete the data are.

Detailed description: The field of nuclear medicine has expanded rapidly since its inception in the mid-20th century, with nuclear medicine technologists now potentially experiencing higher levels of radiation exposure relative to other medical worker populations. Many radiopharmaceuticals and procedures used in previous decades are now obsolete and are being replaced by new and emerging radioisotopes and combined-modality and molecular imaging procedures. While improvements in imaging technologies and the introduction of certain radioisotopes have generally reduced patient exposure to radiation, nuclear medicine technologists have become increasingly specialized in these newer procedures and are performing these and other nuclear medicine procedures with increasing frequency. Furthermore, lead aprons are less effective in protecting workers during nuclear medicine procedures, specifically higher-energy procedures (e.g., positron emission tomography (PET)), compared to other radiation-related procedures, and are seldom used by technologists performing nuclear medicine. As a result, cumulative doses to nuclear medicine technologists are expected to have increased. We hypothesize that certified nuclear medicine technologists may experience higher risks of some radiation-related cancers and other adverse health outcomes compared to most other medical specialty groups. There is currently very little information about radiation-related risks associated with performing these procedures due, in part, to limited information on occupational doses associated with current nuclear medicine practices. To characterize organ-specific doses that could later be used to quantify risks for specific radiation-related disease outcomes, either directly (through subsequent follow-up) or indirectly (through risk projection methods), we plan to collect detailed work history information on nuclear medicine procedures and associated radiation safety practices, as well as badge doses, for a representative sample of 1,500 technologists certified in nuclear medicine in the U.S. This information will complement similar data collected in 2013-2014 from an independent sample of approximately 4,500 general radiologic technologists in the U.S. Radiologic Technologists Study (USRT) who had reported working with these procedures. However, unlike the USRT sample, the proposed sample is expected to be higher-risk, including only those workers with a specialty certification in nuclear medicine who will have been begun working with nuclear medicine procedures much earlier in their career, at ages associated with greater susceptibility to radiation-related carcinogenesis.

Eligibility criteria: * ELIGIBILITY CRITERIA:
* Technologists from the target population of approximately 25,000 individuals who were first certified in nuclear medicine technology in the U.S. after 1980, are currently alive and residing in the U.S., and are not participants of the USRT study.

Primary outcomes:
measure: U.S. nuclear medicine tecnologist
timeFrame: 2016-2022
Secondary outcomes:
measure: Administer questionnaire
timeFrame: 2016-2018
measure: Obtain badge doses
timeFrame: 2016-2019
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Public Health Environmental Health Sciences
state: Minnesota
Study officials:
affiliation: National Cancer Institute (NCI)
name: Cari M Kitahara
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drozdovitch V, Brill AB, Callahan RJ, Clanton JA, DePietro A, Goldsmith SJ, Greenspan BS, Gross MD, Hays MT, Moore SC, Ponto JA, Shreeve WW, Melo DR, Linet MS, Simon SL. Use of radiopharmaceuticals in diagnostic nuclear medicine in the United States: 1960-2010. Health Phys. 2015 May;108(5):520-37. doi: 10.1097/HP.0000000000000261.
citation: Kitahara CM, Linet MS, Drozdovitch V, Alexander BH, Preston DL, Simon SL, Freedman DM, Brill AB, Miller JS, Little MP, Rajaraman P, Doody MM. Cancer and circulatory disease risks in US radiologic technologists associated with performing procedures involving radionuclides. Occup Environ Med. 2015 Nov;72(11):770-6. doi: 10.1136/oemed-2015-102834. Epub 2015 Jul 28.
citation: Drozdovitch V, Brill AB, Mettler FA Jr, Beckner WM, Goldsmith SJ, Gross MD, Hays MT, Kirchner PT, Langan JK, Reba RC, Smith GT, Bouville A, Linet MS, Melo DR, Lee C, Simon SL. Nuclear medicine practices in the 1950s through the mid-1970s and occupational radiation doses to technologists from diagnostic radioisotope procedures. Health Phys. 2014 Oct;107(4):300-10. doi: 10.1097/HP.0000000000000107.