Pre-Op MRI for Tonsil Cancer

JL
Overseen ByJonathan Lee, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an MRI before surgery can predict the success of removing HPV-linked tonsil cancer using transoral robotic surgery. The researchers aim to determine if the MRI can reveal the extent of cancer remaining after surgery. Adults with HPV-positive tonsil cancer considering robotic surgery may qualify for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this pre-operative MRI is safe for predicting margin status in TORS for HPV+ tonsillar SCC?

Research has shown that transoral robotic surgery (TORS) safely treats HPV-positive tonsil cancer. Studies have found that TORS is widely used and carries a very low risk of serious complications, allowing most patients to handle it well. One study found that TORS is safe and effective, particularly for patients with small head and neck cancers. These findings suggest that TORS could be a dependable treatment with manageable risks for those considering this surgery.12345

Why are researchers excited about this trial?

Researchers are excited about using pre-operative MRI for tonsil cancer because it provides a detailed view of the tumor before surgery, which isn't standard in current treatment protocols. Traditional methods often rely on CT scans or physical exams, which may not capture the full extent of the cancer. MRI offers more precise imaging, potentially allowing surgeons to plan more effective and less invasive procedures, like transoral robotic surgery. By improving surgical outcomes and reducing recovery time, this approach could significantly enhance patient care.

What evidence suggests that pre-operative MRI is effective for predicting margin status in HPV+ tonsil cancer?

Studies have shown that transoral robotic surgery (TORS) effectively treats HPV-positive tonsillar squamous cell carcinoma, a type of throat cancer. The disease-specific survival rate exceeds 93%, indicating that most patients live without cancer recurrence. Patients treated with TORS have a locoregional control rate of about 92%, meaning the cancer remains controlled in its original area. Research also shows an excellent overall survival rate, with 91% of patients surviving for at least two years. These results suggest that TORS is a strong option for treating this type of cancer.13567

Are You a Good Fit for This Trial?

This trial is for individuals with HPV+ tonsillar squamous cell carcinoma who are candidates for transoral robotic surgery (TORS). The study will use pre-op MRI to predict if cancer cells have been completely removed. Participants must be suitable for MRI and TORS.

Inclusion Criteria

I am being considered for a specific surgery for HPV+ tonsil cancer.
I am 18 years old or older.

Exclusion Criteria

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
I am under 18 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative MRI

Participants undergo a pre-operative MRI to evaluate the pharyngeal constrictor muscle using a five-point grading scale

1 week
1 visit (in-person)

Surgery

Participants undergo transoral robotic surgery (TORS) for HPV+ tonsillar squamous cell carcinoma

1 week
1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes and margin status post-surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transoral Robotic Surgery
Trial Overview The study tests whether a pre-operative MRI can accurately predict the 'margin status'—if all cancer was removed—in patients undergoing TORS for HPV+ tonsillar SCC. It involves standard MR neck scans, with additional sequences focused on the tonsils.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Pre-operative MRIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Citations

Oncologic Outcomes After Transoral Robotic SurgeryThe 2-year locoregional control rate was 91.8% (95% CI, 87.6%-94.7%), disease-specific survival 94.5% (95% CI, 90.6%-96.8%), and overall survival 91% (95% CI, ...
Transoral Laser or Robotic Surgery Outcomes for ...Disease-specific survival rates in excess of 93% for HPV-positive OPSCC have been reported by Dalton et al and O'Hara et al in the UK. TLM ...
Transoral robotic surgery-based therapy for HPV-related ...The disease-specific survival and overall survival rate was 100% at 3 years, and 95.1% at 5 years. TORS-related complications occurred in 5 ...
Transoral Robotic Surgery in the Multidisciplinary Care of ...For the entire cohort, an LRC rate of 92% was achieved and no difference in recurrence rates were seen between those with and without an ...
Meta-analysis of margins and outcomes after transoral ...A total of 7 articles comprising 1150 patients were included in the analysis. The majority were tonsil primary (54 %), T1-T2 (94 %), and N+ (86 %).
A single centre analysis of outcomes and patterns of failure ...Our outcomes show that single modality TORS treatment is safe and efficacious in patients with small volume head and neck cancer with low-risk ...
Transoral Robotic Surgery Adoption and Safety in Treatment ...TORS has become widely adopted and remains safe across the country, with very low risk of severe complications comparable to nonrobotic surgery.
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