Recruiting

Pre-operative MRI

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07060261

Conditions

Human Papilloma Virus Related Carcinoma

Tonsillar Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transoral robotic surgery+MRI

Study Details

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

Study ID

NCT07060261

Start date

Nov 26, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Pre-operative MRI

Interventions

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.

Primary outcome measure

  • Accuracy as assessed by 5-point MRI score [ Time Frame: Perioperative ]

Central Contacts and Locations

Central contacts

Jonathan Lee, MD

216-445-9390LEEJ13@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Transoral robotic surgery (TORS)
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-05-05.