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Completed

NCT Number: NCT03580161

Simplification of Low Level Internal Dosimetry

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18-F FDG PET/CT dosimetry scans and measurements

Other

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

Ga-68 PSMA PET/CT dosimetry scans and measurements

Other

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

68-Ga Dotatate PET/CT dosimetry scans and measurements

Other

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

99mTc Pertechnetate Thyroid dosimetry scans and measurements

Other

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

99mTc DMSA(III) Renal dosimetry scans and measurements

Other

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

99mTc MAG3 Renal dosimetry scans and measurements

Other

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

99mTc MDP/HDP Bone dosimetry scans and measurements

Other

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

Primary outcomes

  1. The uncertainty on the absorbed dose calculation

    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.

Secondary outcomes

  1. The range of absorbed doses delivered

    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.

Other outcomes

  1. The range of risk estimates

    Time frame: 6-24 hours

    The range of risk estimates associated with diagnostic procedures, derived from the absorbed doses.

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Acronym: SOLLID

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2018
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.