[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523850":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":41,"centralContacts":48,"locations":53,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":40,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":40,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":56,"whyStopped":40,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Volunteer Participants","EXPERIMENTAL","Healthy volunteers will be recruited to evaluate the capability of MRF in conjunction with intravoxel incoherent motion (IVIM) MRI and serve as healthy control data to compare with the participant data.",[13],"Procedure: MRF in conjunction with IVIM MRI without contrast",{"label":15,"type":10,"description":16,"interventionNames":17},"Participants with Radiation Necrosis","The MRI scans (MRF and IVIM) will be performed on participants with newly developed necrosis prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Participants with Tumor Recurrence","The MRI scans (MRF and IVIM) will be performed on participants with newly developed recurrent prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Participants with Brain Metastases","The MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated brain metastases prior to any therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Participants with Primary Gliomas","The MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated primary gliomas prior to any therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Participants with Meningiomas","The MRI scans (MRF and IVIM) will be performed on participants with meningiomas who have not yet undergone radiation or surgical treatment. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"PROCEDURE","MRF in conjunction with IVIM MRI without contrast","MRF in conjunction with IVIM MRI scan, without contrast.",[9,23,31,27,15,19],null,[42,46],{"name":43,"affiliation":44,"role":45},"Lan Lu, PhD","Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":44,"role":45},"Samuel Chao, MD",[49],{"name":43,"role":50,"phone":51,"phoneExt":40,"email":52},"CONTACT","1-866-223 8100","TaussigResearch@ccf.org",[54,71],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center","RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-81.69541,41.4995,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":40,"phoneExt":40,"email":40},"Chaitra A Badve, MD",{"facility":72,"status":56,"city":57,"state":58,"zip":73,"country":60,"countryCode":61,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Cleveland Clinic Taussig Cancer Center","44195",{"type":63,"coordinates":75},[65,66],{"lat":66,"lon":65},[78,80,81],{"name":43,"role":50,"phone":79,"phoneExt":40,"email":40},"866-223-8100",{"name":43,"role":45,"phone":40,"phoneExt":40,"email":40},{"name":47,"role":45,"phone":40,"phoneExt":40,"email":40},{"type":83,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[85],{"name":86,"class":6},"The Cleveland Clinic","100523850","development-of-mrf-for-characterization-of-brain-tumors-after-radiotherapy-100523850",false,"NCT06101069","Development of MRF for Characterization of Brain Tumors After Radiotherapy","Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy","Inclusion Criteria for Healthy Participants:\n\n* Ages 18 - 60\n* No history of cerebrovascular disease\n* No cognitive impairments\n* Able to provide informed consent\n\nInclusion Criteria for Participants with Brain Tumors:\n\n* Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR\n* a. PET identified with developed recurrent tumor or radiation necrosis. OR\n* b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.\n* ECOG performance status 0-2.\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Brain Metastases or Primary Gliomas:\n\n* Radiology identified with developed primary gliomas tumor or brain metastases, OR\n* a. PET identified with developed gliomas tumor or brain metastases, OR\n* b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board\n* Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.\n* Age: 18 years and over\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nInclusion Criteria for Participants with Meningiomas:\n\n* Radiology identified with resectable meningioma\n* Participants have no prior radiation or surgical treatment for brain lesions\n* Age: 18 years or older\n* ECOG performance status 0-2\n* Life expectancy \\> 6 months.\n* Participants with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.\n\nExclusion Criteria:\n\n* Pregnant women OR lactating women\n* Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.\n* Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.\n* The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.\n* Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.\n* Known history of severe claustrophobia.\n* Participants unable to lay still in the scanner for 30 minutes at a time.",true,"ALL","18 Years","60 Years",{"count":99,"type":100},90,"ESTIMATED","INTERVENTIONAL",[103],"NA","The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.\n\nThe primary objectives of this study are:\n\n* To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.\n* To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.\n* To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.",[106,107,108,109],"Brain Tumor","Brain Necrosis","Brain Metastases","Glioma",[111,112],"Magnetic Resonance Fingerprinting","Radiation necrosis","2026-04-29",{"date":115,"type":116},"2026-05-05","ACTUAL",{"date":118,"type":116},"2024-10-14",{"date":120,"type":100},"2026-09",{"name":5,"class":6},2]