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

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

NCT ID: NCT05843032

Condition: Squamous Cell Carcinoma
Tongue SCC
Head and Neck Cancer

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell

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

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: 3D ultrasound, MRI, resected specimen examination by surgeon
Description: 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.
Arm group label: Tongue tumor resection

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Rigshospitalet

Address:
City: Copenhagen
Zip: 2100
Country: Denmark

Contact:
Last name: Tobias Todsen, MD, PhD

Phone: +4535452071
Email: tobias.todsen@regionh.dk

Start date: May 15, 2023

Completion date: February 15, 2024

Lead sponsor:
Agency: Rigshospitalet, Denmark
Agency class: Other

Source: Rigshospitalet, Denmark

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05843032