Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-30 @ 7:28 AM
Study NCT ID:
NCT07060261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Op MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The neuroradiologists will be blinded to each others score'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'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.', 'timeFrame': 'Perioperative'}, {'measure': 'Percentage of participants who received adjuvant therapy, stratified by MRI grade.', 'timeFrame': 'Perioperative'}, {'measure': 'Predictive value of tumor size and diffusion/perfusion MRI parameters for post-operative surgical margin status', 'timeFrame': 'Perioperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transoral robotic surgery (TORS)', 'MRI'], 'conditions': ['Human Papilloma Virus Related Carcinoma', 'Tonsillar Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTherefore, 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥ 18 years of age.\n2. Participants being considered for TORS for HPV+ tonsillar SCC.\n\nExclusion Criteria:\n\n1. Participants \\< 18 years of age.\n2. Participants who cannot provide informed consent.\n3. Participants who do not wish to participate.\n4. Vulnerable populations, including but not limited to cognitively impaired persons, pregnant women, and students or house staff under the direct supervision of the investigator.\n5. Participants in whom MRI is contraindicated.'}, 'identificationModule': {'nctId': 'NCT07060261', 'briefTitle': 'Pre-Op MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Prospective Evaluation of Pre-Operative MRI on Margin Status for Transoral Robotic Surgery for HPV+ Tonsillar Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CASE5325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-operative MRI', 'interventionNames': ['Procedure: Transoral robotic surgery+MRI']}], 'interventions': [{'name': 'Transoral robotic surgery+MRI', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Pre-operative MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Lee Jonathan, MD', 'role': 'CONTACT'}], 'facility': 'Case Comprehensive Cancer Center, Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Jonathan Lee, MD', 'role': 'CONTACT', 'email': 'LEEJ13@ccf.org', 'phone': '216-445-9390'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}