[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07060261":3,"trial-entities:NCT07060261":85,"trial-summary:NCT07060261":89},{"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":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":60,"locations":63,"central_contacts":77,"overall_officials":82,"references":83,"see_also_links":84},"NCT07060261","CASE5325","Pre-Op MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma","Prospective Evaluation of Pre-Operative MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma","RECRUITING","2026-09","2026-04","2026-05-05","2025-11-26","Case Comprehensive Cancer Center","OTHER",true,"This prospective research study aims to see if pre-operative MRI can predict the margin status after transoral robotic surgery (TORS) for human papillomavirus positive (HPV+) tonsillar squamous cell carcinoma (SCC). The pre-operative MRI will have a standard MR neck without and with contrast, with added axial T2 weighted sequence and T2 SPACE sequence through the tonsils. Three neuroradiologists will grade the thickness of the pharyngeal constrictor muscle (the muscle that surrounds the tonsils) on a five-point scale. The study will determine if the pre-operative MRI grading will correlate with positive, insecure (\\\u003C1mm), or secure (\\>1mm) margin during TORS surgery for your HPV+ tonsillar SCC.","There has been a marked increase in the incidence on oropharyngeal SCC in recent decades because of the rise of HPV+ disease1-3. Stage I or II tonsillar SCC can be treated by either surgery or radiation with similar good outcomes. For tumors treated surgically, transoral robotic surgery has replaced open surgery due to decreased morbidity and improved local control. It has been shown that margin status of 1.1mm of healthy tissue around the tumor is sufficient for adequate local control. However, approximately 8.1% of the time there is a positive or insecure margin, resulting in added adjuvant radiation and possibly chemotherapy, with increasing morbidity for each added treatment modality.\n\nTherefore, there is a need to determine pre-operatively the chance of positive or insecure margin at surgery to avoid increased morbidity with added adjuvant treatment. Currently, the most commonly used imaging modality is computed tomography (CT) or magnetic resonance imaging (MRI), but this is to rule out absolute contraindications such as internal carotid artery encasement, involvement of the mandibular periosteum, prevertebral fascia\u002Fmusculature, or masticator space musculature. Recently, a retrospective study used a novel five-point grading scale (1, normal constrictor; 2, bulging constrictor; 3, thinning constrictor; 4, obscured constrictor; and 5, tumor protrusion into the parapharyngeal fat) to evaluate the pharyngeal constrictor muscle, showing that higher scores with obscured constrictor or tumor protrusion into the parapharyngeal fat resulted in increased risk of positive or insecure margin. Given this, there is need for a prospective study to estimate the accuracy of the five-point MRI score with respect to distinguishing patients who go onto have secure surgical margins versus patients who go on to have insecure\u002Fpositive surgical margins including surgical report of violation of anatomic boundaries (pharyngeal constrictor muscle)",[19,20],"Human Papilloma Virus Related Carcinoma","Tonsillar Squamous Cell Carcinoma",[22,23],"Transoral robotic surgery (TORS)","MRI","INTERVENTIONAL","DIAGNOSTIC",[27],"NA",{"count":29,"type":30},30,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"PROCEDURE","Transoral robotic surgery+MRI","During the standard of care MRI, there will be an added T2 and T2 SPACE sequences. These sequences are estimated to take an additional 6 minutes, with no added risk to the patient.",[37],"Pre-operative MRI",[39],{"measure":40,"description":41,"timeFrame":42},"Accuracy as assessed by 5-point MRI score","Accuracy will be summarized using the area under the receiver operating characteristics curve (AUC)","Perioperative",[44,46,48,50],{"measure":45,"timeFrame":42},"Number of Grade 5 cases missed by pre-operative CT versus pre-operative MRI",{"measure":47,"timeFrame":42},"Percentage of patients who received adjuvant treatment, stratified by MRI grade.",{"measure":49,"timeFrame":42},"Percentage of participants who received adjuvant therapy, stratified by MRI grade.",{"measure":51,"timeFrame":42},"Predictive value of tumor size and diffusion\u002Fperfusion MRI parameters for post-operative surgical margin status","ALL","18 Years",null,false,{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Adults ≥ 18 years of age.\n2. Participants being considered for TORS for HPV+ tonsillar SCC.\n\nExclusion Criteria:\n\n1. Participants \\\u003C 18 years of age.\n2. Participants who cannot provide informed consent.\n3. Participants who do not wish to participate.\n4. Vulnerable populations, including but not limited to cognitively impaired persons, pregnant women, and students or house staff under the direct supervision of the investigator.\n5. Participants in whom MRI is contraindicated.",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":74},"Case Comprehensive Cancer Center, Cleveland Clinic Foundation","Cleveland","Ohio","44195","United States",[71],{"name":72,"role":73},"Lee Jonathan, MD","CONTACT",{"lat":75,"lon":76},41.4995,-81.69541,[78],{"name":79,"role":73,"phone":80,"email":81},"Jonathan Lee, MD","216-445-9390","LEEJ13@ccf.org",[],[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[20],[88],"HPV",{"nct_id":4,"found":15,"summary":90,"prompt_version":100},{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an interventional study planning to enroll 30 participants. It is designed to see if adding specific MRI sequences can improve predictions for surgical outcomes.","completed","Pre-Op MRI for HPV+ Tonsillar Squamous Cell Carcinoma","This study is looking at whether a special type of MRI scan before surgery can help predict how much healthy tissue will be around the tumor after transoral robotic surgery (TORS) for HPV-positive tonsil cancer. You would have a standard MRI, but with an extra 6 minutes of specific imaging sequences (T2 and T2 SPACE). Doctors will then use these images to grade the muscle around your tonsils. The goal is to see if this MRI grading can accurately tell if the surgical edges (margins) will be clear of cancer, or if there might be cancer cells left behind, which could help avoid extra treatments later. This study is for adults aged 18 and older who are considering TORS for HPV-positive tonsil cancer.","The primary outcome, accuracy of the MRI score, is measured at the perioperative (around the time of surgery) period. No longer-term follow-up is specified.",123,"You would undergo a standard MRI scan with an additional 6 minutes of specialized imaging sequences. The study does not specify further visits or procedures.","Not stated in the trial record.",[],"v2"]