Clinical trial NCT05843032: 3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma
Tongue SCC
Head and Neck Cancer
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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Accuracy of the 3D ultrasound and MRI compared to the conventional method in measurements of the surgical margins in the resected tongue SCC specimens.
timeFrame: 2 weeks
measure: 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
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of cases requiring adjuvant treatments (surgery or chemo/radiotherapy)
timeFrame: 2 weeks
measure: Shrinkage of the surgical specimen due to formalin fixation based on the specimen volume measurements on 3D ultrasound images before and after formalin fixation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Hovedstaden
Study officials:
References:
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