- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580161
Simplification of Low Level Internal Dosimetry (SOLLID)
Study Overview
Status
Conditions
Intervention / Treatment
- Other: 18-F FDG PET/CT dosimetry scans and measurements
- Other: Ga-68 PSMA PET/CT dosimetry scans and measurements
- Other: 68-Ga Dotatate PET/CT dosimetry scans and measurements
- Other: 99mTc Pertechnetate Thyroid dosimetry scans and measurements
- Other: 99mTc DMSA(III) Renal dosimetry scans and measurements
- Other: 99mTc MAG3 Renal dosimetry scans and measurements
- Other: 99mTc MDP/HDP Bone dosimetry scans and measurements
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Yvonne Fox-Miller
- Phone Number: +44 208 661 3760
- Email: Yvonne.Fox-Miller@rmh.nhs.uk
Study Contact Backup
- Name: Shital Patel
- Phone Number: +44 208 915 6624
- Email: Shital.Patel@rmh.nhs.uk
Study Locations
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Glenn Flux, Royal Marsden NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR 4767
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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