Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
12 participants
OBSERVATIONAL
2018-06-30
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
NCT03519659
Assessing Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System
NCT05496920
Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy
NCT04903340
A Study to Investigate the Whole Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand Fluoride-18 (18F)-JNJ-64326067 in Healthy Participants
NCT03581916
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
NCT00503178
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
18-F FDG PET/CT
Patients receiving routine diagnostic scan
18-F FDG PET/CT dosimetry scans and measurements
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
Ga-68 PSMA PET/CT dosimetry scans and measurements
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
68-Ga Dotatate PET/CT dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc Pertechnetate Thyroid Scan
Patients receiving routine diagnostic scan
99mTc Pertechnetate Thyroid dosimetry scans and measurements
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
99mTc DMSA(III) Renal dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MAG3 Renal Scan
Patients receiving routine diagnostic scan
99mTc MAG3 Renal dosimetry scans and measurements
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
99mTc MDP/HDP Bone dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
18-F FDG PET/CT dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Ga-68 PSMA PET/CT dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
68-Ga Dotatate PET/CT dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc Pertechnetate Thyroid dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc DMSA(III) Renal dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MAG3 Renal dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
99mTc MDP/HDP Bone dosimetry scans and measurements
Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Paediatric patients 18 years of age and under.
* Pregnant patients.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Glenn Flux
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCR 4767
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.