Human Papilloma Virus Related CarcinomaNCT07060261
Pre-Op MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma
A study testing Transoral robotic surgery+MRI in people with Human Papilloma Virus Related Carcinoma and Tonsillar Squamous Cell Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papilloma Virus Related Carcinoma, Tonsillar Squamous Cell Carcinoma
- What is being tested?
- Transoral robotic surgery+MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age.
- Participants being considered for TORS for HPV+ tonsillar SCC.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Lee Jonathan, MD
About this study
Official title: Prospective Evaluation of Pre-Operative MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma
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.
Read the detailed description
There has been a marked increase in the incidence on oropharyngeal SCC in recent decades because of the rise of HPV+ disease1-3. Stage I or II tonsillar SCC can be treated by either surgery or radiation with similar good outcomes. For tumors treated surgically, transoral robotic surgery has replaced open surgery due to decreased morbidity and improved local control. It has been shown that margin status of 1.1mm of healthy tissue around the tumor is sufficient for adequate local control. However, approximately 8.1% of the time there is a positive or insecure margin, resulting in added adjuvant radiation and possibly chemotherapy, with increasing morbidity for each added treatment modality.
Therefore, there is a need to determine pre-operatively the chance of positive or insecure margin at surgery to avoid increased morbidity with added adjuvant treatment. Currently, the most commonly used imaging modality is computed tomography (CT) or magnetic resonance imaging (MRI), but this is to rule out absolute contraindications such as internal carotid artery encasement, involvement of the mandibular periosteum, prevertebral fascia/musculature, or masticator space musculature. Recently, a retrospective study used a novel five-point grading scale (1, normal constrictor; 2, bulging constrictor; 3, thinning constrictor; 4, obscured constrictor; and 5, tumor protrusion into the parapharyngeal fat) to evaluate the pharyngeal constrictor muscle, showing that higher scores with obscured constrictor or tumor protrusion into the parapharyngeal fat resulted in increased risk of positive or insecure margin. Given this, there is need for a prospective study to estimate the accuracy of the five-point MRI score with respect to distinguishing patients who go onto have secure surgical margins versus patients who go on to have insecure/positive surgical margins including surgical report of violation of anatomic boundaries (pharyngeal constrictor muscle)
- Being tested
- Transoral robotic surgery+MRI
- Keywords
- Transoral robotic surgery (TORS), MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral robotic surgery+MRIProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative MRI | Experimental | Not described Receives: Procedure: Transoral robotic surgery+MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy as assessed by 5-point MRI score
Accuracy will be summarized using the area under the receiver operating characteristics curve (AUC)
Measured: Perioperative
Secondary outcomes (4)
Number of Grade 5 cases missed by pre-operative CT versus pre-operative MRI
Measured: Perioperative
Percentage of patients who received adjuvant treatment, stratified by MRI grade.
Measured: Perioperative
Percentage of participants who received adjuvant therapy, stratified by MRI grade.
Measured: Perioperative
Predictive value of tumor size and diffusion/perfusion MRI parameters for post-operative surgical margin status
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start26 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060261
- Sponsor's protocol ID
- CASE5325
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Pre-Operative MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07060261
- Acronym / sponsor ID
- CASE5325
- Keywords
- Transoral robotic surgery (TORS), MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There has been a marked increase in the incidence on oropharyngeal SCC in recent decades because of the rise of HPV+ disease1-3. Stage I or II tonsillar SCC can be treated by either surgery or radiation with similar good outcomes. For tumors treated surgically, transoral robotic surgery has replaced open surgery due to decreased morbidity and improved local control. It has been shown that margin status of 1.1mm of healthy tissue around the tumor is sufficient for adequate local control. However, approximately 8.1% of the time there is a positive or insecure margin, resulting in added adjuvant radiation and possibly chemotherapy, with increasing morbidity for each added treatment modality.
Therefore, there is a need to determine pre-operatively the chance of positive or insecure margin at surgery to avoid increased morbidity with added adjuvant treatment. Currently, the most commonly used imaging modality is computed tomography (CT) or magnetic resonance imaging (MRI), but this is to rule out absolute contraindications such as internal carotid artery encasement, involvement of the mandibular periosteum, prevertebral fascia/musculature, or masticator space musculature. Recently, a retrospective study used a novel five-point grading scale (1, normal constrictor; 2, bulging constrictor; 3, thinning constrictor; 4, obscured constrictor; and 5, tumor protrusion into the parapharyngeal fat) to evaluate the pharyngeal constrictor muscle, showing that higher scores with obscured constrictor or tumor protrusion into the parapharyngeal fat resulted in increased risk of positive or insecure margin. Given this, there is need for a prospective study to estimate the accuracy of the five-point MRI score with respect to distinguishing patients who go onto have secure surgical margins versus patients who go on to have insecure/positive surgical margins including surgical report of violation of anatomic boundaries (pharyngeal constrictor muscle)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative MRI | Experimental | Procedure: Transoral robotic surgery+MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥ 18 years of age.
- Participants being considered for TORS for HPV+ tonsillar SCC.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral robotic surgery+MRIDuring 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. | Procedure or surgery | Pre-operative MRI |
Primary outcome
Accuracy as assessed by 5-point MRI score
Time frame: Perioperative
Accuracy will be summarized using the area under the receiver operating characteristics curve (AUC)
4 secondary outcomes
Number of Grade 5 cases missed by pre-operative CT versus pre-operative MRI
Time frame: Perioperative
Percentage of patients who received adjuvant treatment, stratified by MRI grade.
Time frame: Perioperative
Percentage of participants who received adjuvant therapy, stratified by MRI grade.
Time frame: Perioperative
Predictive value of tumor size and diffusion/perfusion MRI parameters for post-operative surgical margin status
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral robotic surgery+MRI in people with Human Papilloma Virus Related Carcinoma and Tonsillar Squamous Cell Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Lee, MD (216-445-9390, LEEJ13@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy as assessed by 5-point MRI score (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.