Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06405256
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-04', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-cranial progression-free survival (IPFS)', 'timeFrame': 'From the date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first, assessed up to 12 months.', 'description': 'Defined as the time from date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Local control rate (LCR)', 'timeFrame': 'Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.', 'description': 'LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.', 'description': 'Defined as the time from the date of radiation to the date of any documented death due to any cause.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.', 'description': 'The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria.\n\nComplete Response (CR): Disappearance of all target lesions; Partial Response (PR): \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.', 'description': 'DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria.\n\nComplete Response (CR): Disappearance of all target lesions; Partial Response (PR): \\>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.'}, {'measure': 'Adverse Event', 'timeFrame': 'AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.', 'description': 'The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by EORTC/RTOG Radiation Grading System Criteria and CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging-guided Adaptive Radiotherapy'], 'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'This study is an ambispective cohort study to evaluate the displacement and deformation of large brain metastases (BM) treated with magnetic resonance imaging-guided adaptive radiotherapy (MRIgART)', 'detailedDescription': 'All patients had a pathologically confirmed malignant cancer and were diagnosed with brain metastases (BM) by enhanced magnetic resonance imaging (MRI) with BM volume of 2cm and above. All patients received Unity MR-linac adaptive radiotherapy. Gross tumor volume (GTV) and organs at risk (OARs) were re-delineated for every image set and analyzed for displacement and deformation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years; KPS score ≥ 60.\n2. pathologically confirmed lung cancer.\n3. diagnosed with brain metastases by enhanced MRI.\n4. BM volume ≥ 2cm.\n5. Anticipated time to survival\\>3 months.\n6. Treated with Unity MR-linac.\n7. Good compliance; Able to stay still in supine position for 45 minutes and above.\n\nExclusion Criteria:\n\n1. Fail to complete radiotherapy as planned; Anticipated time to survival less than 3 months.\n2. Suffer from severe back pain in supine position, unable to receive Unity MR-linac.\n3. Suffer from severe claustrophobia.\n4. Incomplete pre-Unity image data.'}, 'identificationModule': {'nctId': 'NCT06405256', 'briefTitle': 'Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Displacement and Deformation Analysis of Adaptive Radiotherapy Based on MR-Linac for Large Brain Metastases', 'orgStudyIdInfo': {'id': 'BMMRIgART'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BM patients receiving MRIgART', 'description': 'For it\'s an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART"', 'interventionNames': ['Radiation: magnetic resonance imaging-guided adaptive radiotherapy']}], 'interventions': [{'name': 'magnetic resonance imaging-guided adaptive radiotherapy', 'type': 'RADIATION', 'description': 'Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)', 'armGroupLabels': ['BM patients receiving MRIgART']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nan Bi, MD, PhD', 'role': 'CONTACT', 'email': 'binan_email@163.com', 'phone': '+861087788799'}], 'facility': 'Chinese Academy of Medical Science and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Nan Bi, MD', 'role': 'CONTACT', 'email': 'binan_email@163.com', 'phone': '8601087788799'}, {'name': 'Yuchao Ma, MD', 'role': 'CONTACT', 'email': 'mycbyts@126.com'}], 'overallOfficials': [{'name': 'Nan Bi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences and Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}