Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04865718
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}], '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': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood flow visible in laser speckle contrast images', 'timeFrame': 'during surgical procedure', 'description': 'Ability of laser speckle contrast images to reveal blood flow during surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aneurysm, Brain', 'Arteriovenous Malformation of Brain', 'Neurovascular Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing cerebral blood flow during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll adults planned for craniotomy procedures such as planned resections for brain tumor or neurovascular procedure such as aneurysm or arteriovenous malformation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years or older).\n* Size of craniotomy at least 2 cm.\n* Possibility of intraoperative ICGA.\n* Able to render written informed consent.\n\nExclusion Criteria:\n\n* Patients unable to legally consent.\n* Patients with impaired cognitive function.'}, 'identificationModule': {'nctId': 'NCT04865718', 'briefTitle': 'Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow', 'orgStudyIdInfo': {'id': '2018040045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neurovascular surgery group', 'description': 'Subjects undergoing neurovascular surgery including aneurysm clipping', 'interventionNames': ['Diagnostic Test: ICGA imaging']}], 'interventions': [{'name': 'ICGA imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'subjects undergoing intraoperative ICGA imaging', 'armGroupLabels': ['neurovascular surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78701', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristina Adrean', 'role': 'CONTACT', 'email': 'kadrean@ascension.org', 'phone': '512-324-9999', 'phoneExt': '10025'}], 'facility': 'Dell Seton Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Andrew Dunn, PhD', 'role': 'CONTACT', 'email': 'adunn@utexas.edu', 'phone': '512-232-2808'}, {'name': 'Kristina Adrean, RN', 'role': 'CONTACT', 'email': 'kadrean@ascension.org', 'phone': '512-324-9999', 'phoneExt': '10025'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}