Brain CancerNCT02911155
Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
An observational study of Brain Cancer and Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Cancer, Thyroid Cancer, Circulatory Disease
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2016to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, School of Public Health Environmental Health Sciences
Minneapolis, Minnesota, 55455
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Brain Cancer, Thyroid Cancer, Circulatory Disease, Breast Cancer
- Keywords
- Cohort Study, Radiation, Occupation
- Medical subject headings
- Brain Neoplasms, Thyroid Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| US Nuclear Medicine Technologist | radiologic technologists certified in nuclear medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
U.S. nuclear medicine tecnologist
Cancer and other disease risks associated with occupational nuclear medicine radiation exposures
Measured: 2016-2022
Secondary outcomes (2)
Administer questionnaire
Collect data on nuclear medicine procedures performed, radioisotopes used, related work and safety practices, and places of employment over time.
Measured: 2016-2018
Obtain badge doses
Collect badge doses from the nation's largest commercial dosimetry provider for use in estimating occupational radiation exposures.
Measured: 2016-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start21 Sep 2016
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Cari M Kitahara, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911155
- Sponsor's protocol ID
- 999916141
- Other IDs
- 16-C-N141
- Status last verified
- May 2020
- First submitted
- 21 Sep 2016
- Last updated
- 5 May 2020
- Results posted
- No
Publications
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.
PubMed 25811150Kitahara 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.
PubMed 26220810Drozdovitch 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.
PubMed 25162420
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
- ClinicalTrials.gov ID
- NCT02911155
- Acronym / sponsor ID
- 999916141
- Conditions
- Brain Cancer, Thyroid Cancer, Circulatory Disease, Breast Cancer
- Keywords
- Cohort Study, Radiation, Occupation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Sep 2016
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US Nuclear Medicine Technologist | – | –radiologic technologists certified in nuclear medicine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
U.S. nuclear medicine tecnologist
Time frame: 2016-2022
Cancer and other disease risks associated with occupational nuclear medicine radiation exposures
2 secondary outcomes
Administer questionnaire
Time frame: 2016-2018
Obtain badge doses
Time frame: 2016-2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Background: PubMed 25811150Drozdovitch 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.
- Background: PubMed 26220810Kitahara 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.
- Background: PubMed 25162420Drozdovitch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cari M Kitahara principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
U.S. nuclear medicine tecnologist (time frame: 2016-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02911155, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.