Head and Neck Cancer, Squamous Cell Carcinoma, Tongue SCC
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DIAGNOSTIC_TEST3D ultrasound, MRI, resected specimen examination by surgeon
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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Denmark
Contacts
Primary ContactFatemeh Makouei, PhD
Backup ContactTobias Todsen, MD, PhD
Outcome results
None listed