Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-28 @ 9:55 AM
Study NCT ID:
NCT06937268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DOTATATE PET for Meningioma Radiation Planning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target radiation volume', 'timeFrame': '2 years', 'description': 'The volume of gross total volume (GTV), clinical target volume (CTV), planned target volume (PTV) contours, and volume of dose exposure to normal brain tissue using standard imaging and DOTATE-PET scan'}], 'secondaryOutcomes': [{'measure': 'Local control', 'timeFrame': '2 years'}, {'measure': 'Progression-free survival', 'timeFrame': '2 years'}, {'measure': 'Perceived usefulness by radiation oncologist', 'timeFrame': '2 years'}, {'measure': 'Adverse event', 'timeFrame': '2 years'}, {'measure': 'Rate of DOTATATE-scan completion', 'timeFrame': '2 years'}, {'measure': 'Extent of post-operative disease volume compared to MRI', 'timeFrame': '2 years'}, {'measure': 'Overall survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningioma']}, 'descriptionModule': {'briefSummary': '68Ga-DOTATATE-based radionuclides are a novel modality in the diagnosis and treatment of central nervous system meningioma. DOTATATE is a ligand for the SSTR (somatostatin receptor), which is expressed in meningioma but not in normal brain or bone. It is also more effective than MRI in delineating tumor, which is the current imaging standard for assessing meningioma. For radiation planning, it can help to reduce the risk of geometrical miss, identify area that require dose-escalation, and reduce dose to normal tissue. The purpose of the study is to compare the radiation therapy (RT) contouring and planning for meningioma with and without the use of 68Ga-DOTATATE-PET'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Able and willing to comply with the study procedures\n* Intact meningioma requiring definitive radiation\n* Post-operative meningioma requiring adjuvant radiation\n* No prior radiation therapy or medical therapy directed at the tumour\n\nExclusion Criteria:\n\n* Breastfeeding or pregnancy\n* Claustrophobia or inability to lie still in a supine position\n* Unwillingness or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06937268', 'acronym': 'DOTATATE-RT', 'briefTitle': 'DOTATATE PET for Meningioma Radiation Planning', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'Exploratory Analysis of DOTATATE PET for Meningioma Radiation Planning', 'orgStudyIdInfo': {'id': 'H22-03733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DOTATATE-PET scan', 'interventionNames': ['Diagnostic Test: DOTATATE-PET scan']}], 'interventions': [{'name': 'DOTATATE-PET scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'DOTATATE tracer PET scan for meningioma', 'armGroupLabels': ['DOTATATE-PET scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Sandy Chang', 'role': 'CONTACT', 'email': 'sandy.chang@bccancer.bc.ca', 'phoneExt': '6048776000'}, {'name': 'Justin Oh, BA, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BC Cancer - Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Sandy Chang', 'role': 'CONTACT', 'email': 'sandy.chang@bccancer.bc.ca', 'phone': '6048776000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}