Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT04073966
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2019-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D049292', 'term': 'Leukoaraiosis'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association between Changes in Functional Connectivity and Neurocognitive Changes', 'timeFrame': 'One year after SRS completion', 'description': 'Correlation between magnitude of neurocognitive function decline and severity of radiation-induced brain injury'}], 'primaryOutcomes': [{'measure': 'Radiation-Induced White Matter Injury', 'timeFrame': 'One year after SRS completion', 'description': 'Dose-dependent reductions in white matter integrity, as quantified by Diffusion Tensor MRI (DTI)-derived measures of change in diffusivity'}], 'secondaryOutcomes': [{'measure': 'Changes in Functional Connectivity', 'timeFrame': 'One year after SRS completion', 'description': 'Dose-dependent alterations in functional connectivity, especially for the subsystems of the Default Mode Network (DMN), as measured by resting state functional MRI'}, {'measure': 'Neurocognitive Changes', 'timeFrame': 'One year after SRS completion', 'description': 'Change in neurocognitive function, as measured by Delis-Kaplan testing, after SRS treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases', 'Neurocognitive Deficit', 'White Matter Alterations', 'Radiation Exposure']}, 'descriptionModule': {'briefSummary': 'Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.', 'detailedDescription': 'The proposed study aims to provide novel and useful information for clinicians, both to help predict potential neurocognitive changes following SRS, and as a possible guide for SRS treatment alteration, whether through adjustment of dose or beam arrangements in relation to white matter tracts. In this observational pilot study of 20 patients, the association between RT-associated brain injury and neurocognitive function will be quantitatively assessed longitudinally over one year following SRS. The study team hypothesizes that, over this time, (1) there will be radiation dose-dependent reductions in regional white matter tract integrity and reduction in functional connectivity in the default mode network of gray matter, (2) there will be measurable decline in neurocognitive function, and (3) there will be an association between severity of radiation-induced brain injury on MRI and magnitude of neurocognitive functional decline. This association will relate, in part, to the location(s) affected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed brain metastasis being treated with SRS.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic diagnosis of cancer\n* Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.\n* Patients are permitted to have undergone craniotomy and resection of metastasis/metastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.\n* Anticipated life expectancy at least 1 year\n* Age ≥ 18 years\n* Ability to read and comprehend written English and follow instructions in English\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Previous radiation to the brain or head\n* Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years\n* Previous severe head or brain injury\n* History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia\n* Prisoners"}, 'identificationModule': {'nctId': 'NCT04073966', 'briefTitle': 'MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study', 'orgStudyIdInfo': {'id': 'LCCC 1844'}}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily C Goldman', 'role': 'CONTACT', 'email': 'emily_goldman@med.unc.edu', 'phone': '984-974-8441'}, {'name': 'Colette J Shen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tong Zhu, PhD, DABR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina at Chapel Hill, Department of Radiation Oncology', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Becky Green', 'role': 'CONTACT', 'email': 'rlgreen@med.unc.edu', 'phone': '9849748440'}], 'overallOfficials': [{'name': 'Colette J Shen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina at Chapel Hill, Department of Radiation Oncology'}, {'name': 'Tong Zhu, PhD, DABR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina at Chapel Hill, Department of Radiation Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}