Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
| Tonsillar Squamous Cell Carcinoma | Tonsillar Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transoral robotic surgery+MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre-operative MRI
- interventionNames
- Procedure: Transoral robotic surgery+MRI
Primary outcomes (1)
- measure
- Accuracy as assessed by 5-point MRI score
- timeFrame
- Perioperative
- description
- Accuracy will be summarized using the area under the receiver operating characteristics curve (AUC)
Secondary outcomes (4)
- measure
- Number of Grade 5 cases missed by pre-operative CT versus pre-operative MRI
- timeFrame
- Perioperative
- measure
- Percentage of patients who received adjuvant treatment, stratified by MRI grade.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available