Skip to content

Simplification of Low Level Internal Dosimetry

Simplification of Low Level Internal Dosimetry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03580161
Acronym
SOLLID
Enrollment
12
Registered
2018-07-09
Start date
2018-06-30
Completion date
2022-06-30
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure to Medical Diagnostic Radiation

Keywords

Absorbed Radiation Dose, Radiation Risks, Radiation Protection, Dosimetry

Brief summary

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.

Detailed description

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.

Interventions

OTHER18-F FDG PET/CT dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

OTHERGa-68 PSMA PET/CT dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

OTHER68-Ga Dotatate PET/CT dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

OTHER99mTc Pertechnetate Thyroid dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

OTHER99mTc DMSA(III) Renal dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

OTHER99mTc MAG3 Renal dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

OTHER99mTc MDP/HDP Bone dosimetry scans and measurements

Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

Sponsors

Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\* All patients able to undergo the procedures necessary to acquire sufficient data for dosimetry, consisting of up 7 nuclear medicine scans and 10 external radiation retention measurements over a time period of up to 24 hours

Exclusion criteria

* Patients unable or unwilling to undergo further procedures that may include scans and external retention measurements. * Paediatric patients 18 years of age and under. * Pregnant patients.

Design outcomes

Primary

MeasureTime frameDescription
The uncertainty on the absorbed dose calculation6-24 hoursThe 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.

Secondary

MeasureTime frameDescription
The range of absorbed doses delivered6-24 hoursThe 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.

Other

MeasureTime frameDescription
The range of risk estimates6-24 hoursThe range of risk estimates associated with diagnostic procedures, derived from the absorbed doses.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026