Surgical Margin Assessment by 3D Ultrasound

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT05740774

Collaborator

(none)

Enrollment

Location

Arm

3.9

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tongue Cancer Squamous Cell Carcinoma Head and Neck Cancer	Diagnostic Test: 3D ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Feasibility of 3D Ultrasound in the Assessment of Resection Margins During Surgery for Squamous Cell Carcinoma of the Tongue: a Comparison With Histopathology

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tongue tumor resection	Diagnostic Test: 3D ultrasound 3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.

Arm

Intervention/Treatment

Experimental: Tongue tumor resection

Diagnostic Test: 3D ultrasound

3D ultrasound scanning of the resected tongue tumor will be performed. The margin analysis will be made using the 3D ultrasound image.

Outcome Measures

Primary Outcome Measures

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