Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-31 @ 1:41 PM
Study NCT ID:
NCT03580161
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2018-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simplification of Low Level Internal Dosimetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-26', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-07-06', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The range of risk estimates', 'timeFrame': '6-24 hours', 'description': 'The range of risk estimates associated with diagnostic procedures, derived from the absorbed doses.'}], 'primaryOutcomes': [{'measure': 'The uncertainty on the absorbed dose calculation', 'timeFrame': '6-24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The range of absorbed doses delivered', 'timeFrame': '6-24 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Absorbed Radiation Dose', 'Radiation Risks', 'Radiation Protection', 'Dosimetry'], 'conditions': ['Exposure to Medical Diagnostic Radiation']}, 'referencesModule': {'references': [{'pmid': '32903035', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'A study to develop practical methods of accurate low radiation absorbed dose measurement in patients referred for nuclear medicine scans.\n\nThere 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.\n\nOver 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.\n\nFive 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* 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\n\nExclusion Criteria:\n\n* Patients unable or unwilling to undergo further procedures that may include scans and external retention measurements.\n* Paediatric patients 18 years of age and under.\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT03580161', 'acronym': 'SOLLID', 'briefTitle': 'Simplification of Low Level Internal Dosimetry', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Simplification of Low Level Internal Dosimetry', 'orgStudyIdInfo': {'id': 'CCR 4767'}}, 'armsInterventionsModule': {'armGroups': [{'label': '18-F FDG PET/CT', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: 18-F FDG PET/CT dosimetry scans and measurements']}, {'label': 'Ga-68 PSMA PET/CT', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: Ga-68 PSMA PET/CT dosimetry scans and measurements']}, {'label': '68-Ga Dotatate PET/CT', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: 68-Ga Dotatate PET/CT dosimetry scans and measurements']}, {'label': '99mTc Pertechnetate Thyroid Scan', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: 99mTc Pertechnetate Thyroid dosimetry scans and measurements']}, {'label': '99mTc DMSA(III) Renal Scan', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: 99mTc DMSA(III) Renal dosimetry scans and measurements']}, {'label': '99mTc MAG3 Renal Scan', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: 99mTc MAG3 Renal dosimetry scans and measurements']}, {'label': '99mTc MDP/HDP Bone Scan', 'description': 'Patients receiving routine diagnostic scan', 'interventionNames': ['Other: 99mTc MDP/HDP Bone dosimetry scans and measurements']}], 'interventions': [{'name': '18-F FDG PET/CT dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['18-F FDG PET/CT']}, {'name': 'Ga-68 PSMA PET/CT dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['Ga-68 PSMA PET/CT']}, {'name': '68-Ga Dotatate PET/CT dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['68-Ga Dotatate PET/CT']}, {'name': '99mTc Pertechnetate Thyroid dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['99mTc Pertechnetate Thyroid Scan']}, {'name': '99mTc DMSA(III) Renal dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['99mTc DMSA(III) Renal Scan']}, {'name': '99mTc MAG3 Renal dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['99mTc MAG3 Renal Scan']}, {'name': '99mTc MDP/HDP Bone dosimetry scans and measurements', 'type': 'OTHER', 'description': 'Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans', 'armGroupLabels': ['99mTc MDP/HDP Bone Scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Glenn Flux', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}