Pre-Op MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma

NCT07060261 | Recruiting DMC

• 1 other identifier: CASE5325
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus Related Carcinoma; Tonsillar Squamous Cell Carcinoma

Keywords

Transoral robotic surgery (TORS); MRI

Outcome Measures

Primary Outcomes (1)

• Accuracy as assessed by 5-point MRI score

  Accuracy will be summarized using the area under the receiver operating characteristics curve (AUC)

  Perioperative

Secondary Outcomes (4)

• Number of Grade 5 cases missed by pre-operative CT versus pre-operative MRI

  Perioperative

• Percentage of patients who received adjuvant treatment, stratified by MRI grade.

  Perioperative

• Percentage of participants who received adjuvant therapy, stratified by MRI grade.

  Perioperative

• Predictive value of tumor size and diffusion/perfusion MRI parameters for post-operative surgical margin status

  Perioperative

Study Arms (1)

Pre-operative MRI

EXPERIMENTAL

Procedure: Transoral robotic surgery+MRI

Interventions

Transoral robotic surgery+MRI PROCEDURE

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.

Pre-operative MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age.
• Participants being considered for TORS for HPV+ tonsillar SCC.

You may not qualify if:

• Participants \< 18 years of age.
• Participants who cannot provide informed consent.
• Participants who do not wish to participate.
• Vulnerable populations, including but not limited to cognitively impaired persons, pregnant women, and students or house staff under the direct supervision of the investigator.
• Participants in whom MRI is contraindicated.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Central Study Contacts

Jonathan Lee, MD

CONTACT

216-445-9390; LEEJ13@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The neuroradiologists will be blinded to each others score
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)