Surgical Margin Assessment by 3D Ultrasound

February 22, 2023 updated by: Fatemeh Makouei, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Dk-015
      • København Ø, Dk-015, Denmark, 2100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the surgical margin measurements of the 3D ultrasound to histopathology
Time Frame: 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.
2 weeks
Diagnostic accuracy
Time Frame: 2 weeks
number of margins correctly classified as free (> 5 mm), close (< 5 mm) or positive (<1 mm) margin
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21017915a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Available for 5 years

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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