3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

Study Overview
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Brief Summary
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In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.

Detailed Description
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Cancer surgery is the primary treatment in the early stages of tongue squamous cell carcinoma (SCC), and the goal is the complete resection of the tumor with an adequate margin of healthy tissue around to ensure proper cancer removal. Inadequate margins lead to a high risk of local cancer recurrence and the patient will need re-surgery or adjuvant therapies. Ex-vivo imaging of the resected surgical specimen has been suggested to provide information for margin assessment and thus improve cancer surgery. In this manuscript, a protocol to investigate the clinical benefit of three-dimensional (3D) ultrasound imaging of the surgical margins and comparing the results to magnetic resonance imaging (MRI) and the clinical examination of the surgical specimen by surgeon (palpation to inspect the resected tissue) has been designed. Tumor segmentation and margin measurement (Anterior towards apex of tongue, posterior towards base of tongue, medial towards back of tongue, lateral towards floor of mouth, and profound/deep margins) will be performed by head and neck surgeons on 3D ultrasound images and by two consultant radiologists on MRI of the ex-vivo specimen. Accuracy of each method will be evaluated by computing the proportion of correctly classified margins (positive, close, and free) by each technique with respect to the gold standard histopathology.

Official Title
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3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Clinical Evaluation, MRI, and Histopathology

Conditions
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Squamous Cell Carcinoma, Tongue SCC, Head and Neck Cancer

Intervention / Treatment
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* Diagnostic Test: 3D ultrasound, MRI, resected specimen examination by surgeon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment T1-T3 staging on cross-sectional imaging Exclusion Criteria: T4 staging Unable to understand the verbal or written information Prior radiotherapy treatment of oral cavity cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongue tumor resection<br> | Diagnostic Test: 3D ultrasound, MRI, resected specimen examination by surgeon<br>* 3D ultrasound and MR scanning of the resected tongue tumor will be performed. The resected surgical specimen will also be examined by the surgeon to assess the margins. The accuracy of the margin assessment by 3D ultrasound, MRI, and surgeon examination will be evaluated by correlating the results to the final histopathology findings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens. |  | 2 weeks | 
| Diagnostic accuracy - number of margins correctly classified as free (> 5 mm), close (1- 5 mm) or positive (<1 mm) margin by 3D ultrasound and MRI using histopathology findings as the reference |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy) |  | 2 weeks | 
| Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, 3D ultrasound, Ultrasonography, Three dimensional imaging, cancer diagnosis, surgical margin assessment, magnetic resonance imaging, MRI, ex-vivo surgical specimen imaging, squamous cell carcinoma, histopathology, SCC, oral cancer