Surgical Margin Assessment by 3D Ultrasound

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Tongue Cancer; Squamous Cell Carcinoma
• Interventions: Diagnostic Test: 3D ultrasound

• Registration Number: NCT05740774
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Complete removal of cancer encircled by a secure margin of healthy tissue is the aim of surgical oncology. A close or positive surgical margin reported by pathologist typically ends in adjuvant therapies (re-surgery and/or radiotherapy), which come with prognostic risks and financial cost. Therefore, ex-vivo imaging of removed cancer tissue may assist in margin evaluation. In this study, investigators aimed to investigate the correlation of 3D ultrasound to histopathology to assess tongue tumor margin status.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-11
• Study First Submitted QC: 2023-02-22
• Last Update Submitted: 2023-02-22
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment
• T1-T2 staging on cross-sectional imaging

Exclusion Criteria

• Age < 18 yrs
• T3-T4 staging
• Unable to understand the verbal or written information
• Prior radiotherapy treatment of oral cavity cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tongue tumor resection	3D ultrasound	-

Primary Outcome Measures

Name	Time	Method
Correlation of the surgical margin measurements of the 3D ultrasound to histopathology	2 weeks	The smallest margin will be measured in mm on 3D ultrasound image of the ex-vivo surgical specimen. Correlation of the measurement to the final histopathology result will be investigated.
Diagnostic accuracy	2 weeks	number of margins correctly classified as free (\> 5 mm), close (\< 5 mm) or positive (\<1 mm) margin

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 København Ø, Dk-015, Denmark