[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382884":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":83,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":54,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":54,"enrollmentInfo":98,"targetDuration":54,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":54,"overallStatus":68,"whyStopped":54,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort I (MRI after radiation therapy)","EXPERIMENTAL","Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.",[13,14,15,16],"Other: Contrast Agent","Procedure: Magnetic Resonance Imaging","Other: Quality-of-Life Assessment","Other: Questionnaire Administration",{"label":18,"type":10,"description":19,"interventionNames":20},"Cohort II (MRI after surgery)","Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.",[13,14,15,16],[22,31,45,51],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Contrast Agent","Given IV",[9,18],[27,28,29,30],"Contrast","Contrast Drugs","contrast material","Contrast Medium",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Magnetic Resonance Imaging","Undergo MRI",[9,18],[37,38,39,40,41,42,43,44],"Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Quality-of-Life Assessment","Ancillary studies",[9,18],[50],"Quality of Life Assessment",{"type":6,"name":52,"description":47,"armGroupLabels":53,"otherNames":54},"Questionnaire Administration",[9,18],null,[56],{"name":57,"affiliation":5,"role":58},"Stephen Y Lai","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":54,"email":64},"Stephen Y. Lai","CONTACT","713-792-6920","sylai@mdanderson.org",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-95.36327,29.76328,{"lat":78,"lon":77},[81,82],{"name":61,"role":62,"phone":63,"phoneExt":54,"email":54},{"name":61,"role":58,"phone":54,"phoneExt":54,"email":54},{"type":84,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR",[86],{"name":87,"class":88},"National Cancer Institute (NCI)","NIH","100382884","phase-4-serial-magnetic-resonance-imaging-for-the-prediction-of-radiation-induced-changes-in-normal-tissue-of-patients-with-oral-cavity-or-skull-base-tumors-100382884",false,"NCT04265430","Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors","Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury","Inclusion Criteria:\n\nAll Cohorts:\n\n* Patients older than 18 years of age\n* Patients with good performance status (ECOG score 0-2)\n* Patients willing to give written informed consent.\n\nCohort 1 (Individuals without ORN or MRONJ):\n\n* Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.\n* Patients currently dispositioned to treatment with radiotherapy and\u002For antiresorptive or antiangiogenic medication therapy\n\nCohort 2 (Individuals with ORN or MRONJ):\n\n* Patients with a clinical diagnosis of ORN or MRONJ following treatment for cancer\n* Patients previously dispositioned to treatment with radiotherapy and\u002For antiresorptive or antiangiogenic medication therapy\n\nExclusion Criteria:\n\n* Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR \\\u003C 30ml\u002Fmin\u002F1.73m2.\n* Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)","ALL","18 Years",{"count":99,"type":100},425,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).",[106,107,108],"Malignant Oral Cavity Neoplasm","Malignant Skull Base Neoplasm","Osteoradionecrosis","2026-05-19",{"date":111,"type":112},"2026-05-22","ACTUAL",{"date":114,"type":112},"2018-09-17",{"date":116,"type":100},"2031-09-01",{"name":5,"class":6},1]