Exposure to Medical Diagnostic RadiationSOLLIDNCT03580161
Simplification of Low Level Internal Dosimetry
An observational study of Exposure to Medical Diagnostic Radiation, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exposure to Medical Diagnostic Radiation
- What is being tested?
- 18-F FDG PET/CT dosimetry scans and measurements, Ga-68 PSMA PET/CT dosimetry scans and measurements and 68-Ga Dotatate PET/CT dosimetry scans and measurements
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2018to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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.
Read the 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.
- Conditions
- Exposure to Medical Diagnostic Radiation
- Being tested
- 18-F FDG PET/CT dosimetry scans and measurements, Ga-68 PSMA PET/CT dosimetry scans and measurements, 68-Ga Dotatate PET/CT dosimetry scans and measurements, 99mTc Pertechnetate Thyroid dosimetry scans and measurements, 99mTc DMSA(III) Renal dosimetry scans and measurements
- Keywords
- Absorbed Radiation Dose, Radiation Risks, Radiation Protection, Dosimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-F FDG PET/CT dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Ga-68 PSMA PET/CT dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
68-Ga Dotatate PET/CT dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc Pertechnetate Thyroid dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc DMSA(III) Renal dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MAG3 Renal dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MDP/HDP Bone dosimetry scans and measurementsOther
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
| Study group | Role | What they receive |
|---|---|---|
| 18-F FDG PET/CT | Patients receiving routine diagnostic scan Receives: Other: 18-F FDG PET/CT dosimetry scans and measurements | |
| Ga-68 PSMA PET/CT | Patients receiving routine diagnostic scan Receives: Other: Ga-68 PSMA PET/CT dosimetry scans and measurements | |
| 68-Ga Dotatate PET/CT | Patients receiving routine diagnostic scan Receives: Other: 68-Ga Dotatate PET/CT dosimetry scans and measurements | |
| 99mTc Pertechnetate Thyroid Scan | Patients receiving routine diagnostic scan Receives: Other: 99mTc Pertechnetate Thyroid dosimetry scans and measurements | |
| 99mTc DMSA(III) Renal Scan | Patients receiving routine diagnostic scan Receives: Other: 99mTc DMSA(III) Renal dosimetry scans and measurements | |
| 99mTc MAG3 Renal Scan | Patients receiving routine diagnostic scan Receives: Other: 99mTc MAG3 Renal dosimetry scans and measurements | |
| 99mTc MDP/HDP Bone Scan | Patients receiving routine diagnostic scan Receives: Other: 99mTc MDP/HDP Bone dosimetry scans and measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The uncertainty on the absorbed dose calculation
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.
Measured: 6-24 hours
Secondary outcomes (1)
The range of absorbed doses delivered
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.
Measured: 6-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start30 Jun 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exposure to Medical Diagnostic RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Flux, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580161
- Sponsor's protocol ID
- CCR 4767
- Acronym
- SOLLID
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2018
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flux G, Murray I, Rushforth D, Gape P, Abreu C, Lee M, Ribeiro A, Gregory R, Chittenden S, Thurston J, Du Y, Gear J. SOLLID - a single centre study to develop methods to investigate the effects of low radiation doses within nuclear medicine, to enable multicentre epidemiological investigations. Br J Radiol. 2021 Mar 1;94(1119):20200072. doi: 10.1259/bjr.20200072. Epub 2020 Sep 9.
PubMed 32903035
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplification of Low Level Internal Dosimetry
- ClinicalTrials.gov ID
- NCT03580161
- Acronym / sponsor ID
- SOLLID / CCR 4767
- Conditions
- Exposure to Medical Diagnostic Radiation
- Keywords
- Absorbed Radiation Dose, Radiation Risks, Radiation Protection, Dosimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 18-F FDG PET/CT | – | Other: 18-F FDG PET/CT dosimetry scans and measurementsPatients receiving routine diagnostic scan |
| Ga-68 PSMA PET/CT | – | Other: Ga-68 PSMA PET/CT dosimetry scans and measurementsPatients receiving routine diagnostic scan |
| 68-Ga Dotatate PET/CT | – | Other: 68-Ga Dotatate PET/CT dosimetry scans and measurementsPatients receiving routine diagnostic scan |
| 99mTc Pertechnetate Thyroid Scan | – | Other: 99mTc Pertechnetate Thyroid dosimetry scans and measurementsPatients receiving routine diagnostic scan |
| 99mTc DMSA(III) Renal Scan | – | Other: 99mTc DMSA(III) Renal dosimetry scans and measurementsPatients receiving routine diagnostic scan |
| 99mTc MAG3 Renal Scan | – | Other: 99mTc MAG3 Renal dosimetry scans and measurementsPatients receiving routine diagnostic scan |
| 99mTc MDP/HDP Bone Scan | – | Other: 99mTc MDP/HDP Bone dosimetry scans and measurementsPatients receiving routine diagnostic scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-F FDG PET/CT dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | 18-F FDG PET/CT |
| Ga-68 PSMA PET/CT dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | Ga-68 PSMA PET/CT |
| 68-Ga Dotatate PET/CT dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | 68-Ga Dotatate PET/CT |
| 99mTc Pertechnetate Thyroid dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | 99mTc Pertechnetate Thyroid Scan |
| 99mTc DMSA(III) Renal dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | 99mTc DMSA(III) Renal Scan |
| 99mTc MAG3 Renal dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | 99mTc MAG3 Renal Scan |
| 99mTc MDP/HDP Bone dosimetry scans and measurementsParticipants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans | Other | 99mTc MDP/HDP Bone Scan |
Primary outcome
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.
1 secondary outcome
The range of absorbed doses delivered
Time frame: 6-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 32903035Flux G, Murray I, Rushforth D, Gape P, Abreu C, Lee M, Ribeiro A, Gregory R, Chittenden S, Thurston J, Du Y, Gear J. SOLLID - a single centre study to develop methods to investigate the effects of low radiation doses within nuclear medicine, to enable multicentre epidemiological investigations. Br J Radiol. 2021 Mar 1;94(1119):20200072. doi: 10.1259/bjr.20200072. Epub 2020 Sep 9.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Flux principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Medical Diagnostic Radiation, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The uncertainty on the absorbed dose calculation (time frame: 6-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.