Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 4:57 AM
Study NCT ID:
NCT00603694
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2008-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hippocampal Radiation Exposure and Memory
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2008-01-16', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hippocampus', 'Memory', 'Radiation'], 'conditions': ['Arteriovenous Malformation', 'Schwannoma', 'Trigeminal Neuralgia']}, 'descriptionModule': {'briefSummary': 'Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.\n\nIn this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have consented to GK radiosurgery or cranial radiation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for radiosurgery for benign disorders (Groups 1\\&2).\n* Patients planned for prophylactic cranial irradiation (Group 3)\n\nExclusion Criteria:\n\n* Previous cranial radiation\n* Severe psychiatric disorder\n* Severe cognitive or memory impairment (MMSE \\< 21)\n* Non-English speaking, which will potentially make memory testing difficult and unreliable.\n* Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures\n* Patients on steroid medications.\n* Left hand dominant patients\n* Dose exposure to left hippocampus \\>0.5Gy and \\<2Gy. We will attempt to estimate dose to hippocampus prior to enrollment using pre-planning on diagnostic imaging to minimize exclusion of patients due to dose exposure \\>0.5 Gy and \\< 2Gy following baseline memory testing.\n* Benzodiazepine or narcotics given on the day of radiotherapy/radiosurgery prior to completion of the study procedures\n* Previous brain surgery within one year prior to radiosurgery\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT00603694', 'briefTitle': 'Hippocampal Radiation Exposure and Memory', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Hippocampal Radiation Exposure and Memory: A Pilot Study', 'orgStudyIdInfo': {'id': '07-0023-CE'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '(Experimental group): Receiving \\> 2 Gy SRS to left hippocampus (n=10)'}, {'label': '2', 'description': '(Low-dose control group): Receiving \\< 0.5 Gy SRS to left hippocampus (n=10)'}, {'label': '3', 'description': '(High-dose control group): Receiving whole brain PCI (n=10)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}