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

Rigshospitalet

Status: Not yet enrolling

Conditions: Squamous Cell Carcinoma; Head and Neck Cancer; Tongue SCC

Treatments: Diagnostic Test: 3D ultrasound, MRI, resected specimen examination by surgeon

Study type: Interventional

Funder types: Other

Identifiers

NCT05843032

21017915

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Tongue tumor resection

Experimental group

Treatment:

Diagnostic Test: 3D ultrasound, MRI, resected specimen examination by surgeon