Pre-Op MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Case Comprehensive Cancer Center
- Study ID
- NCT07060261
- Status
- Recruiting
Conditions
- Human Papilloma Virus Related Carcinoma
- Tonsillar Squamous Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Transoral robotic surgery+MRI — PROCEDUREDuring 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.
Study Details
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 (\<1mm), or secure (\>1mm) margin during TORS surgery for your HPV+ tonsillar SCC.
Key Dates
- Start date
- Nov 26, 2025
- Status verified
- Apr 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Pre-operative MRI
Primary Outcome Measure
Accuracy as assessed by 5-point MRI score [ Time Frame: Perioperative ]
Central Contacts
- Jonathan Lee, MD216-445-9390
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Case Comprehensive Cancer Center, Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Lee Jonathan, MD |