Simplification of Low Level Internal Dosimetry (SOLLID)

June 26, 2023 updated by: Royal Marsden NHS Foundation Trust
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Royal Marsden Hospital patients undergoing diagnostic nuclear medicine procedures to assess bone marrow involvement, kidney function, thyroid function, staging of adult malignancies and glucose metabolism.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
18-F FDG PET/CT
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Ga-68 PSMA PET/CT
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
68-Ga Dotatate PET/CT
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc Pertechnetate Thyroid Scan
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc DMSA(III) Renal Scan
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MAG3 Renal Scan
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MDP/HDP Bone Scan
Patients receiving routine diagnostic scan
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The range of risk estimates
Time Frame: 6-24 hours
The range of risk estimates associated with diagnostic procedures, derived from the absorbed doses.
6-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Glenn Flux, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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