Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-05 @ 5:45 PM
Study NCT ID:
NCT05233904
Status:
UNKNOWN
Last Update Posted:
2022-06-13
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Centre (TIC) on Treatment Day', 'timeFrame': '1 Treatment Day', 'description': 'This is defined as the total time in hours spent at the cancer centre from the scheduled CT simulation (Arrm 1) or treatment delivery (Arm 2) appointment until beam delivery completion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Cancer Requiring Palliative Radiation']}, 'referencesModule': {'references': [{'pmid': '36482335', 'type': 'DERIVED', 'citation': "O'Neil M, Nguyen TK, Laba J, Dinniwell R, Warner A, Palma DA. DART: diagnostic-CT-enabled planning: a randomized trial in palliative radiation therapy (study protocol). BMC Palliat Care. 2022 Dec 9;21(1):220. doi: 10.1186/s12904-022-01115-y."}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to assess the efficacy, acceptability, and scalability of diagnostic-CT-enabled planning, compared to conventional CT simulation planning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Able to provide informed consent\n* Patient has consented to PRT to bone/soft tissue metastases or primary targets in the thorax, abdomen, or pelvis and RO will use simple planning techniques (i.e. parallel-opposed pair or direct field beam arrangement)\n* Patient will be scheduled for same-day simulation and treatment (if randomized to Arm 1)\n* Patient has a pre-existing and recent (i.e. within 4 weeks of time of enrollment) diagnostic CT or CT-fused scan with full visualization of the region-of-interest which has been acquired from an approved diagnostic scanner\n* Patient positioning scan is deemed acceptable and reproducible (e.g., patient is lying supine and relatively flat, there is no/minimal motion blur, ect.)\n* Intravenous (IV)/oral contrast in the region-of-interest is permitted as long as it does not create artifact which obscured the target volume (density override calculations may be required)\n\nExclusion Criteria:\n\n* Any contraindication to receiving radiation\n* Oncologic emergencies and/or on-call cases\n* Pregnant or lactating women\n* Cases requiring composite dosimetric planning to account for previous radiotherapy or extended distance set-up'}, 'identificationModule': {'nctId': 'NCT05233904', 'acronym': 'DART', 'briefTitle': 'DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy', 'orgStudyIdInfo': {'id': 'DART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': "Patients will be booked for CT simulation and treatment as per the local institution's standard practice.", 'interventionNames': ['Diagnostic Test: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Treatment Workflow', 'description': 'Patients do not require a CT simulation appointment. A radiation treatment appointment will be scheduled on an optical surface guidance-equipped treatment unit as soon as available, but a minimum of 24 hours is required between EBAF processing and fraction 1.', 'interventionNames': ['Diagnostic Test: Diagnostic-CT-enabled Planning']}], 'interventions': [{'name': 'Diagnostic-CT-enabled Planning', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease', 'armGroupLabels': ['Experimental Treatment Workflow']}, {'name': 'Standard of Care', 'type': 'DIAGNOSTIC_TEST', 'description': "Patients will be booked for CT simulation and treatment as per the local institution's standard practice", 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'David Palma, MD', 'role': 'CONTACT', 'email': 'David.Palma@lhsc.on.ca', 'phone': '519-685-8500'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'David Palma, MD', 'role': 'CONTACT', 'email': 'David.Palma@lhsc.on.ca', 'phone': '519-685-8500'}, {'name': "Melissa O'Neil", 'role': 'CONTACT', 'email': 'Melissa.ONeil@lhsc.on.ca'}], 'overallOfficials': [{'name': 'David Palma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre, Lawson Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'David Palma', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}