Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-08 @ 7:31 AM
Study NCT ID:
NCT03812302
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2019-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}], 'ancestors': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '68-Ga HA-DOTATATE PET/CT will be performed in all participants as part of study protocol. Participants will receive an intravenous infusion of 3MBq/kg of 68Ga HA-DOTATATE (to max 200 MBq), followed by CT and PET imaging 60 minutes later. Tracer uptake in each vascular territory will be interpreted qualitatively and quantitatively.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2019-01-18', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)', 'timeFrame': 'time 0 (baseline)'}], 'secondaryOutcomes': [{'measure': 'Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores', 'timeFrame': 'time 0 (baseline)'}, {'measure': 'Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)', 'timeFrame': '6 months'}, {'measure': 'Correlation between vascular DOTATATE uptake scores and clinical status', 'timeFrame': '0 and 6 months'}, {'measure': 'Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure', 'timeFrame': '0 and 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Giant Cell Arteritis']}, 'referencesModule': {'references': [{'pmid': '23653652', 'type': 'RESULT', 'citation': 'Unizony SH, Dasgupta B, Fisheleva E, Rowell L, Schett G, Spiera R, Zwerina J, Harari O, Stone JH. Design of the tocilizumab in giant cell arteritis trial. Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.'}, {'pmid': '40021570', 'type': 'DERIVED', 'citation': 'Clifford AH, Abele J, Hung R, Wuest F, Andersson J, Pike S, Yacyshyn E, Lenza E, Jickling G, Raggi P, Cohen Tervaert JW. Comparison of [18F]fluorodeoxyglucose and [68Ga]Gallium DOTA-TATE in patients with active giant cell arteritis. EJNMMI Rep. 2025 Mar 1;9(1):7. doi: 10.1186/s41824-025-00242-y.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.', 'detailedDescription': 'The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6 months, and tracer uptake will be correlated to clinical disease activity, and medication use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must:\n\n1. Meet the revised GCA diagnosis criteria (modified from ref 1)\n2. Have either newly-diagnosed or relapsing disease\n3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)\n4. Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment\n5. Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.\n\nGCA diagnosis criteria (modified from ref 1, to remove ESR requirement).\n\n1. Age ≥ 50 years\n2. And at least 1 of a. or b. :\n\n 1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication\n 2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness\n3. And at least 1 of a. or b.:\n\n 1. Temporal artery biopsy revealing features of GCA\n 2. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)\n\nExclusion Criteria:\n\n* Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.'}, 'identificationModule': {'nctId': 'NCT03812302', 'briefTitle': 'Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)', 'orgStudyIdInfo': {'id': 'Pro00085448'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DOTATATE', 'description': 'All 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up.', 'interventionNames': ['Diagnostic Test: 68-Ga HA-DOTATATE PET/CT']}], 'interventions': [{'name': '68-Ga HA-DOTATATE PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'See arm description.', 'armGroupLabels': ['DOTATATE']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2G3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Alison Clifford', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}