Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT04715503
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET-imaging of Unruptured Intracranial Aneurysm Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'C504894', 'term': '68Ga-DOTANOC'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET-imaging of unruptured intracranial aneurysms', 'timeFrame': '1 month', 'description': 'Uptake of 18F-FDG or 68Ga-DOTANOC in intracranial arterial aneurysms as compared to contra-lateral normal vessel as SUVmax or TBR.\n\nCorrelation of uptake of 18F-FDG or 68Ga-DOTANOC (SUVmax or TBR) to aneurysm histological findings (CD45, CD3, CD5, CD20, CD138 and CD68, SSTR2, SSTR3 and SSTR5)'}], 'secondaryOutcomes': [{'measure': 'Risk factors for intracranial aneurysm inflammation', 'timeFrame': '1 month', 'description': 'Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracranial aneurysm', 'PET', 'inflammation', 'positron emission tomography', 'rupture risk'], 'conditions': ['Intracranial Aneurysm', 'Cerebral Aneurysm', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '38382960', 'type': 'DERIVED', 'citation': 'Laukka D, Paturi J, Rahi M, Saraste A, Parkkola R, Kivelev J, Gardberg M, Kuhmonen J, Rinne J. PET imaging of unruptured intracranial aneurysm inflammation (PET-IA) study: a feasibility study protocol. BMJ Open. 2024 Feb 20;14(2):e076764. doi: 10.1136/bmjopen-2023-076764.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.', 'detailedDescription': 'Study subjects are patients who are diagnosed with an unruptured saccular intracranial aneurysm and planned for elective surgical treatment of intracranial aneurysms. Prior the planned surgery, all study subjects will undergo PET-imaging of the brain with 18F-FDG- and 68Ga-DOTANOC-tracers targeting glucose metabolism and somatostatin receptors in inflammatory cells. After PET-imaging, samples for histopathological examination from the intracranial aneurysm sac will be collected during the surgery from every study subject. Blood samples are collected prior to aneurysm operation from the routine pre-operative laboratory tests. Cerebrospinal fluid samples are collected during the surgical procedure from the surgical site. From blood samples we will evaluate expression of 20 different circulating microRNAs (miRNA) and the level of tumor necrosis factor-1, interleukin 1 beta, vascular endothelial growth factor, and evaluate correlations between miRNA expression and SUVmax in PET-imaging and miRNA and aneurysm histological findings.\n\nCorrelation between inflammatory findings in histological studies and PET-imaging will be evaluated (correlation of SUVmax to aneurysm histological findings).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fusiform intracranial aneurysms\n* Following medications: Asetylsalisylic acid or non-steroidal anti-inflammatory drugs.\n* Patients who have contraindication for magnetic resonance imaging (Pace Makers, foreign ferromagnetic bodies or implants)\n* Patients who are allergic to contrast agents.\n* Pregnancy\n* Underage persons\n* Patients on somatostatin analogue medication or with known neuroendocrine tumor\n\nExclusion Criteria:\n\n* Patients who are diagnosed with unruptured intracranial aneurysm with MRI/MRA or DSA\n* Patients who are planned to undergo surgical treatment (ligation) of the intracranial aneurysm\n* Age ≥18 and \\<75 years.\n* Saccular intracranial aneurysm with maximum diameter ≥ 3 mm.'}, 'identificationModule': {'nctId': 'NCT04715503', 'acronym': 'PET-IA', 'briefTitle': 'PET-imaging of Unruptured Intracranial Aneurysm Inflammation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'PET-imaging of Unruptured Intracranial Aneurysm Inflammation', 'orgStudyIdInfo': {'id': 'T225/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET-IA', 'description': '68Ga-DOTANOC 18F-FDG', 'interventionNames': ['Radiation: PET imaging, 18F-FDG', 'Radiation: PET imaging, 68Ga-DOTANOC']}], 'interventions': [{'name': 'PET imaging, 18F-FDG', 'type': 'RADIATION', 'description': 'PET-MRI with 18F-FDG', 'armGroupLabels': ['PET-IA']}, {'name': 'PET imaging, 68Ga-DOTANOC', 'type': 'RADIATION', 'description': 'PET-CT with 68Ga-DOTANOC', 'armGroupLabels': ['PET-IA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Dan Laukka, MD', 'role': 'CONTACT', 'email': 'dan.laukka@tyks.fi', 'phone': '+358 2 313 2799'}, {'name': 'Jaakko Rinne, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dan Laukka, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antti Saraste, MD, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Melissa Rahi, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juri Kivelev, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Johanna Kuhmonen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Riitta Parkkola, MD, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Gardberg, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Dan Laukka, MD', 'role': 'CONTACT', 'email': 'dan.laukka@tyks.fi', 'phone': '+358 2 313 2799'}], 'overallOfficials': [{'name': 'Jaakko Rinne, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku'}, {'name': 'Antti Saraste, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Turku University Hospital, Heart Centre, University of Turku'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jaakko Rinne', 'investigatorAffiliation': 'Turku University Hospital'}}}}