Health TrialsbyHealthPanel

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

ConditionsHuman Papilloma Virus Related CarcinomaTonsillar Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥ 18 years of age.

Participants being considered for TORS for HPV+ tonsillar SCC.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Transoral robotic surgery+MRI

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pre-operative MRIExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
Perioperative

Secondary outcomes

1

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

Time frame
Perioperative
2

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

Time frame
Perioperative
3

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

Time frame
Perioperative
4

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

Time frame
Perioperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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