Buccal Cancer Resection Ultrasound Guided (BRUG)

May 1, 2023 updated by: Rob Noorlag, UMC Utrecht

Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study

The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt.

The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life.

In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection.

50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.

Study Type

Interventional

Enrollment (Anticipated)

50

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • buccal mucosal squamous cell carcinoma
  • surgical removal under general anesthesia

Exclusion Criteria:

  • tumor is not visible on ultrasound as echolucent region

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided surgery
Device: Ultrasound-guided resection
Ultrasound-guided resection of buccal squamous cell carcinomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of involved margins
Time Frame: within 2 weeks after surgery
Number of involved margins
within 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of ultrasound for identifying involved margins
Time Frame: within 2 weeks after surgery
accuracy of ultrasound
within 2 weeks after surgery
Number of patients with an indication for local adjuvant therapy
Time Frame: within one month after surgery
need for local adjuvant treatment
within one month after surgery
Quality of life assessed by questionnaires at 4 timepoints
Time Frame: before surgery, at 4, 8, and 12 months after surgery
Influence of treatment on quality of life
before surgery, at 4, 8, and 12 months after surgery

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

University Medical Center Groningen
Medical Center Haaglanden
Rijnstate Hospital
Medisch Spectrum Twente
Antoni van Leeuwenhoek Ziekenhuis

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 (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL83714.041.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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