The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
NCT Number: NCT03580161
This is a pilot study with the primary aim being to identify the minimum number of scans and measurements necessary to determine accurately the absorbed radiation doses delivered from internal sources of radiation administered for diagnostic nuclear medicine procedures.
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All sexes
Observational
Sutton, Surrey, SM2 5PT, United Kingdom
A study to develop practical methods of accurate low radiation absorbed dose measurement in patients referred for nuclear medicine scans.
There is currently very little information on and therefore understanding of the effects of exposure to low levels of radiation on patients or radiation workers. Assumptions are largely based on evidence from high radiation doses following nuclear incidents which may not be applicable to medical procedures. Underestimation of the radiation effects incurs greater risk to patients than is currently assumed, while overestimation can prevent more informative scans that would be obtained from higher administered activities. This research study answers an invitation from the Department of Health Policy research programme to improve our understanding of those low radiation dose risks.
Over 600,000 patients have nuclear medicine scans in the UK each year, presenting an opportunity to accurately measure low radiation doses and follow up the effects on a large number of patients. This study will develop practical methods to measure accurately the radiation doses delivered to patients referred for nuclear medicine positron emission tomography (PET) and single photon emission computed tomography (SPECT) scans.
Five patients referred for each of 7 diagnostic nuclear medicine procedures will undergo up to 7 quantitative PET/SPECT scans and up to 10 whole body radiation retention measurements over the course of 1-2 days to enable the absorbed radiation doses to be calculated accurately. Analysis of subsets of these measurements will be performed to identify the timing and minimum number of measurements necessary for accurate dose estimates.
The longer term aim is that these methods and results will subsequently be used to inform a national epidemiological (epidemiology is the study of factors affecting the health and illness of populations) study on the effects of low doses of radiation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Time frame: 6-24 hours
The uncertainty on the absorbed dose calculation for normal organs and for the whole-body as a function of the number of scans and whole-body counts acquired.
Time frame: 6-24 hours
The range of absorbed doses delivered to healthy organs from 99mTc-MDP/HDP bone imaging, 99mTc- MAG-3 renograms, 99mTc-Pertechnetate thyroid Imaging, 18F-FDG, 68Ga PSMA and 68Ga DOTATATE.
Time frame: 6-24 hours
The range of risk estimates associated with diagnostic procedures, derived from the absorbed doses.
Royal Marsden NHS Foundation Trust
Other
Acronym: SOLLID
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