Simplification of Low Level Internal Dosimetry

Completed

• Conditions: Exposure to Medical Diagnostic Radiation
• Interventions: Other: 68-Ga Dotatate PET/CT dosimetry scans and measurements; Other: 18-F FDG PET/CT dosimetry scans and measurements; Other: Ga-68 PSMA PET/CT dosimetry scans and measurements; Other: 99mTc DMSA(III) Renal dosimetry scans and measurements; Other: 99mTc Pertechnetate Thyroid dosimetry scans and measurements; Other: 99mTc MAG3 Renal dosimetry scans and measurements; Other: 99mTc MDP/HDP Bone dosimetry scans and measurements

• Registration Number: NCT03580161
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2018-06-21
• Study Start: 2018-06-30
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-09
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
68-Ga Dotatate PET/CT	68-Ga Dotatate PET/CT dosimetry scans and measurements	Patients receiving routine diagnostic scan
18-F FDG PET/CT	18-F FDG PET/CT dosimetry scans and measurements	Patients receiving routine diagnostic scan
Ga-68 PSMA PET/CT	Ga-68 PSMA PET/CT dosimetry scans and measurements	Patients receiving routine diagnostic scan
99mTc DMSA(III) Renal Scan	99mTc DMSA(III) Renal dosimetry scans and measurements	Patients receiving routine diagnostic scan
99mTc Pertechnetate Thyroid Scan	99mTc Pertechnetate Thyroid dosimetry scans and measurements	Patients receiving routine diagnostic scan
99mTc MAG3 Renal Scan	99mTc MAG3 Renal dosimetry scans and measurements	Patients receiving routine diagnostic scan
99mTc MDP/HDP Bone Scan	99mTc MDP/HDP Bone dosimetry scans and measurements	Patients receiving routine diagnostic scan

Primary Outcome Measures

Name	Time	Method
The uncertainty on the absorbed dose calculation	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 Outcome Measures

Name	Time	Method
The range of absorbed doses delivered	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.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom