Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-20 @ 4:31 PM
Study NCT ID:
NCT02311556
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to local progression of each treated and evaluable brain metastasis', 'timeFrame': 'At time of radiosurgery and after radiosurgery (approximately 1 week)', 'description': 'Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.'}], 'secondaryOutcomes': [{'measure': 'Radiation necrosis', 'timeFrame': 'Up to 1 year', 'description': 'Radiation necrosis will be defined by pathology, when available. When no pathology is available, clinical diagnosis based on clinical course and management will be used.'}, {'measure': 'Complete response', 'timeFrame': 'Up to 1 year', 'description': 'Complete response = no residue enhancing lesion on MRI'}, {'measure': 'Elsewhere brain failure', 'timeFrame': 'Up to 1 year', 'description': 'Elsewhere brain failure = appearance of brain metastases outside of the prior radiosurgery region which can be diagnosed radiographically and does not required require pathological confirmation.'}, {'measure': 'Clinical deterioration', 'timeFrame': 'Up to 1 year', 'description': 'Clinical deterioration will be assessed based on the Karnofsky Performance scale (KPS).\n\n* 100=Normal no complaints; no evidence of disease.\n* 90=Able to carry on normal activity; minor signs or symptoms of disease.\n* 80=Normal activity with effort; some signs or symptoms of disease.\n* 70=Cares for self; unable to carry on normal activity or to do active work.\n* 60=Requires occasional assistance, but is able to care for most of his personal needs.\n* 50=Requires considerable assistance and frequent medical care.\n* 40=Disabled; requires special care and assistance.\n* 30=Severely disabled; hospital admission is indicated although death not imminent.\n* 20=Very sick; hospital admission necessary; active supportive treatment necessary.\n* 10=Moribund; fatal processes progressing rapidly.\n* 0=Dead'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Brain Metastases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.\n* At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.\n* Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.\n* Patient must be ≥ 18 years of age.\n* Patient must have Karnofsky Performance Status (KPS) of at least 60\n* Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.\n* Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).\n* Patient must not be pregnant or breastfeeding.\n* Patient must not have an estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73m2.\n* Patient must not have melanoma.\n* Patient must not have hemorrhagic lesions.'}, 'identificationModule': {'nctId': 'NCT02311556', 'briefTitle': 'Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '201302018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DSC-PMR', 'description': 'DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery', 'interventionNames': ['Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging']}], 'interventions': [{'name': 'dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging', 'type': 'DEVICE', 'otherNames': ['DSC-PMR'], 'armGroupLabels': ['DSC-PMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Jiayi Huang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}