[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06586892":3,"trial-entities:NCT06586892":91,"trial-summary:NCT06586892":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":35,"sex":36,"minimum_age":37,"maximum_age":21,"healthy_volunteers":38,"eligibility_criteria":39,"std_ages":59,"locations":62,"central_contacts":80,"overall_officials":84,"references":86,"see_also_links":87},"NCT06586892","2024-0406","Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)","RECRUITING","2032-12-30","2026-08","2026-08-14","2025-09-15","M.D. Anderson Cancer Center","OTHER",true,"This research will focus on the prospective qualification and validation of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) candidate biomarkers (i.e., Ktrans and Ve) to assess the natural history of osteoradionecrosis (ORN) and treatment for this devastating complication related to irradiation of head and neck cancers. The investigations will also include assessment of DCE-MRI candidate biomarkers for pre-qualification as quantitative imaging biomarkers of soft-tissue structures.","This prospective observational study will acquire DCE-MRI data from 200 evaluable patients, specifically with an elevated dosimetric risk to assure an event rate of 20% by 36 months post-radiation, sufficient to demonstrate biomarker performance in the clinical cohort most reflective of relative ORN risk. The final study cohort will consist of individuals undergoing definitive radiotherapy for primary head and neck malignancy. The study subjects will include patients with primarily elevated risk of ORN based on clinical (e.g., pre-RT dental procedures) and dosimetric risk factors we established in prior work (e.g., D30\\>50Gy, V44 ≥ 42%, or V58 ≥ 25%). All subjects will receive standard IMRT or IMPT as part of their standard clinical care, and treatment plans delivered will be in no way modified based on experimental imaging. Multi-parametric DCE-MRI imaging will be serially performed as per this study's manual of procedures. Clinical data regarding for evaluation of possible dental, mandibular, as well as other normal tissue organs-at-risk side effects will be collected prospectively from medical and dental records for correlation with the DCE-MRI imaging biomarkers. Functional outcomes and patient-reported outcomes questionnaires will be completed to detail outcomes of the continuum of treatment and survivorship.",[18],"Orodental Injury",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},300,"ESTIMATED",[27],{"type":28,"name":29,"description":30},"BEHAVIORAL","Radiotherapy followed by chemotherapy","Researchers would like to test the accuracy of the MRI data being used for this study. If you agree, you will have 2 additional MRI scans within 2 weeks before Visit 1.\n\nThe first 90 participants who agree will be selected to have the following scans:\n\n* 35 participants will be scanned 2 times on one MRI device (Device #1).\n* 35 participants will be scanned 2 times on another MRI device (Device #2).\n* 20 participants will be scanned 1 time on both MRI devices (Device #1 and #2). If you agree and you are chosen, the study doctor will tell you if you will have scans on\n\n  1. or 2 MRI devices.",[32],{"measure":33,"timeFrame":34},"Overall Survival","Up to 60 months",[],"ALL","18 Years",false,{"inclusion":40,"exclusion":51,"raw_text":58},[41,42,43,44,45,46,47,48,49,50],"Aged 18 years or older.","Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node.","Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy.","Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging).","Be willing to comply with all study procedures.","Be willing to participate for the duration of the study.","Have elevated dosimetric risk mainly characterized by any of the following criteria:","D30\\>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy","V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or","V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more.",[52,53,54,55,56,57],"Having an estimated GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2;","Contraindication to MRI (e.g., non-MRI compatible metallic implants)","Pregnant females","Unable or unwilling to give written, informed consent to undergo MRI imaging.","Claustrophobia","Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.","Inclusion Criteria:\n\nProvide signed and dated informed consent form.\n\n* Aged 18 years or older.\n* Have histologic evidence of malignant neoplasm that may have been obtained from the primary tumor or metastatic lymph node.\n* Have a clinical decision made to receive external beam radiation therapy (EBRT) with curative intent, with or without concomitant chemotherapy.\n* Have a good performance status (ECOG score 0-2) evaluated during screening (4 weeks prior to baseline imaging).\n* Be willing to comply with all study procedures.\n* Be willing to participate for the duration of the study.\n* Have elevated dosimetric risk mainly characterized by any of the following criteria:\n\n  * D30\\>50Gy: 30% of the whole-mandible volume received a dose greater than 50 Gy\n  * V44 ≥ 42%: at least 42% of the volume received a dose of 44 Gy or more or\n  * V58 ≥ 25%: at least 25% of the volume received a dose of 58 Gy or more.\n\nExclusion Criteria:\n\nUnable to tolerate DW-MRI or DCE-MRI;\n\n* Having an estimated GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2;\n* Contraindication to MRI (e.g., non-MRI compatible metallic implants)\n* Pregnant females\n* Unable or unwilling to give written, informed consent to undergo MRI imaging.\n* Claustrophobia\n* Unable to obtain imaging studies of adequate quality to assess imaging-based biomarkers.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":77},"The University of Texas M. D. Anderson Cancer Center","Houston","Texas","77030","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"Stephen Lai, MD, PHD","CONTACT","713-792-6528","sylai@mdanderson.org",{"name":71,"role":76},"PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},29.76328,-95.36327,[81],{"name":82,"role":72,"phone":83,"email":74},"Stephen Lai, MD,PHD","(713) 792-6528",[85],{"name":82,"affiliation":12,"role":76},[],[88],{"label":89,"url":90},"MD Anderson Cancer Center","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":92,"biomarkers":95},[93,94],"Injury to Kidney","Malignant Neoplasm",[],{"nct_id":4,"found":14,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an observational study planning to enroll 300 participants. It will collect data from 200 patients who are at higher risk for orodental injury.","completed","Observational Study of MRI for Orodental Injury After Radiotherapy","This study is looking at how dynamic contrast-enhanced MRI (magnetic resonance imaging) can help understand and track orodental injury (damage to the mouth and teeth) that can happen after radiation therapy for head and neck cancers. Researchers want to see if specific measurements from these MRI scans, called Ktrans and Ve, can be used as reliable indicators of this injury. You might be eligible if you are 18 or older, have a cancer diagnosis, and are planning to receive radiation therapy, with or without chemotherapy, for your head and neck cancer. The study aims to see if these MRI measurements can predict overall survival up to 60 months. The current recruitment status is unclear.","Participants will be followed for overall survival for up to 60 months.",114,"If you agree, you will have 2 additional MRI scans within 2 weeks before your first visit. The first 90 participants who agree will have specific additional scans.","Not stated in the trial record.",[],"v2"]