[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03483337":3,"trial-entities:NCT03483337":102,"trial-summary:NCT03483337":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":15,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":15,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":71,"locations":74,"central_contacts":92,"overall_officials":96,"references":98,"see_also_links":99},"NCT03483337","18-063","New MRI Biomarkers in Head and Neck Cancers","Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers","RECRUITING","2027-03","2026-04","2026-04-14","2018-03-16","Memorial Sloan Kettering Cancer Center","OTHER",null,"Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.\n\nThe purpose of this study is to see if new MRI methods can give us more information about the tumor.",[18,19],"Head and Neck Cancer","Thyroid Cancer",[21,22,23,24,5],"(DW)-MRI","oncological biomarkers","metastatic","recurrent","OBSERVATIONAL",[],{"count":28,"type":29},200,"ESTIMATED",[31,36],{"type":14,"name":32,"description":33,"armGroupLabels":34},"MRI examinations","Patients will be imaged on a 1.5 T or 3 T MR scanner either from GE or Philips. Patients will receive a test-retest scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at main campus, will also be imaged weekly during their course of treatment.",[35],"recurrent or metastatic head and neck cancer patients",{"type":14,"name":32,"description":37,"armGroupLabels":38},"Patients will be imaged on a 1.5 T or 3T MR scanner within one week prior to treatment initiation and at two months and four months after treatment completion (+\u002F- 1 week).",[39],"head and neck cancer or thyroid cancers (differentiated and undifferentiated)",[41,45],{"measure":42,"description":43,"timeFrame":44},"For group 1: number of patients that have biomarkers that maybe early response to therapy indicators","The study is designed to determine if the MRI will provide quantitative imaging biomarkers to predict or assess early treatment response in R\u002FM head and neck cancers. The MR data will be compared with clinical follow-up data. Additional sequence parameters.","1 year",{"measure":46,"description":47,"timeFrame":44},"For group 2: number of patients response to treatment","will be assessed using ROC curves with RECIST with the RECIST version 1.1 response as the gold standard and change in DW-MRI and image feature metrics as predictors.",[],"ALL","18 Years",false,{"inclusion":53,"exclusion":59,"raw_text":70},[54,55,56,57,58],"Age ≥ 18 years","Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.","Group 2 patients:","Biopsy proven recurrent or metastatic or definitive head and neck cancer or (differentiated and undifferentiated) thyroid cancers in the head and neck region only.","Patients planning to undergo reatment at MSK",[60,61,62,63,64,65,66,67,68,69],"Patient would require anesthesia for the study","Patients who are claustrophobic","Patients selecting treatment outside of MSK","Known reaction to Gd based contrast agent","Patients who have presence of a known contradiction to MRI","Pacemaker","Aneurysm clips","Patients with implants that are contradicted for MR imaging will be excluded","Pregnant","Age and mental status wherein he \u002Fshe is unable to cooperate for MRI study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.\n* Group 2 patients:\n\n  * Biopsy proven recurrent or metastatic or definitive head and neck cancer or (differentiated and undifferentiated) thyroid cancers in the head and neck region only.\n  * Patients planning to undergo reatment at MSK\n\nExclusion Criteria:\n\n* Patient would require anesthesia for the study\n* Patients who are claustrophobic\n* Patients selecting treatment outside of MSK\n* Known reaction to Gd based contrast agent\n* Patients who have presence of a known contradiction to MRI\n\n  * Pacemaker\n  * Aneurysm clips\n  * Patients with implants that are contradicted for MR imaging will be excluded\n  * Pregnant\n  * Age and mental status wherein he \u002Fshe is unable to cooperate for MRI study",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"status":8,"city":76,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":89},"New York","10065","United States",[80,84,87],{"name":81,"role":82,"phone":83},"Amita Dave, PhD","CONTACT","212-639-3184",{"name":85,"role":82,"phone":86},"Alan Ho, MD, PhD","646-608-3774",{"name":81,"role":88},"PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},40.71427,-74.00597,[93,95],{"name":81,"role":82,"phone":83,"email":94},"davea@mskcc.org",{"name":85,"role":82,"phone":86},[97],{"name":81,"affiliation":13,"role":88},[],[100],{"label":13,"url":101},"http:\u002F\u002Fwww.mskcc.org\u002Fmskcc\u002Fhtml\u002F44.cfm",{"nct_id":4,"conditions":103,"biomarkers":106},[104,105],"Malignant Head and Neck Neoplasm","Thyroid Gland Carcinoma",[],{"nct_id":4,"found":108,"summary":109,"prompt_version":118},true,{"design":110,"status":111,"heading":6,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study, meaning participants will be monitored without receiving an experimental treatment. It plans to enroll 200 participants.","completed","This study is looking at new ways to use Magnetic Resonance Imaging (MRI) to get more information about head and neck cancers and thyroid cancers. MRI uses magnetic fields and radio waves to create detailed pictures of your body. This study will use special MRI techniques, including diffusion MRI, to see if they can help doctors understand how tumors respond to treatment. You would have MRI scans before treatment, and some patients receiving radiation therapy would have weekly scans during treatment. All participants would also have scans a few months after treatment finishes. The study aims to see if these new MRI methods can identify early signs of how well treatment is working.","The study will measure treatment response and look for biomarkers for one year after treatment.",113,"You would have MRI scans before treatment, and some patients would have weekly scans during radiation therapy. All participants would also have scans two and four months after treatment completion.","Not stated in the trial record.",[],"v2"]