Pre-op MRI to predict margins for TORS in HPV-positive tonsil cancer
Official title: Prospective Evaluation of Pre-Operative MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma
Run by Case Comprehensive Cancer Center · NCT07060261 · Data updated 2026-11-12
This project will test whether a special pre-operative MRI can predict if adults with HPV-positive tonsil cancer will have clear margins after transoral robotic surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | November 26, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07060261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with HPV-positive tonsillar squamous cell carcinoma who are being considered for TORS and can safely undergo MRI are ideal candidates.
✕Probably not a fit
Patients who cannot have MRI, who are under 18, who have non-HPV tumors, or who require non-surgical primary therapy are unlikely to benefit from this imaging prediction approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective study enrolling adults with HPV-positive tonsillar squamous cell carcinoma who are planned for transoral robotic surgery (TORS). Patients will receive a standard neck MRI with and without contrast plus added axial T2 and T2 SPACE sequences through the tonsils. Three neuroradiologists will independently score the pharyngeal constrictor muscle using a five-point grading scale and those scores will be compared to surgical margin status (positive, insecure <1 mm, or secure >1 mm). The aim is to see whether pre-operative MRI grading correlates with intraoperative margin results and could inform pre-surgical planning.
Why it matters
Potential benefit: If successful, the MRI grading could help surgeons predict which patients are likely to have close or positive margins and guide decisions to avoid additional treatments and reduce added morbidity.
How similar studies have gone: A recent retrospective report using the same five-point pharyngeal constrictor grading suggested higher scores correlate with worse margins, but prospective validation is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults ≥ 18 years of age. 2. Participants being considered for TORS for HPV+ tonsillar SCC. Exclusion Criteria: 1. Participants \< 18 years of age. 2. Participants who cannot provide informed consent. 3. Participants who do not wish to participate. 4. Vulnerable populations, including but not limited to cognitively impaired persons, pregnant women, and students or house staff under the direct supervision of the investigator. 5. Participants in whom MRI is contraindicated.
Where it's running
-
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, United States Recruiting
Study contacts
- Study coordinator: Jonathan Lee, MD
- Email: LEEJ13@ccf.org
- Phone: 216-445-9390
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.