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Buccal Cancer Resection Ultrasound Guided (BRUG)

Primary Purpose

Buccal Mucosa Cancer, Squamous Cell Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided resection
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Buccal Mucosa Cancer focused on measuring Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: buccal mucosal squamous cell carcinoma surgical removal under general anesthesia Exclusion Criteria: tumor is not visible on ultrasound as echolucent region

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ultrasound-guided surgery

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of involved margins
    Number of involved margins

    Secondary Outcome Measures

    Sensitivity and specificity of ultrasound for identifying involved margins
    accuracy of ultrasound
    Number of patients with an indication for local adjuvant therapy
    need for local adjuvant treatment
    Quality of life assessed by questionnaires at 4 timepoints
    Influence of treatment on quality of life

    Full Information

    First Posted
    April 18, 2023
    Last Updated
    May 1, 2023
    Sponsor
    UMC Utrecht
    Collaborators
    Rijnstate Hospital, University Medical Center Groningen, Medisch Spectrum Twente, Medical Center Haaglanden, Antoni van Leeuwenhoek Ziekenhuis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05852665
    Brief Title
    Buccal Cancer Resection Ultrasound Guided
    Acronym
    BRUG
    Official Title
    Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UMC Utrecht
    Collaborators
    Rijnstate Hospital, University Medical Center Groningen, Medisch Spectrum Twente, Medical Center Haaglanden, Antoni van Leeuwenhoek Ziekenhuis

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Buccal Mucosa Cancer, Squamous Cell Carcinoma
    Keywords
    Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound-guided surgery
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound-guided resection
    Intervention Description
    Ultrasound-guided resection of buccal squamous cell carcinomas
    Primary Outcome Measure Information:
    Title
    Number of involved margins
    Description
    Number of involved margins
    Time Frame
    within 2 weeks after surgery
    Secondary Outcome Measure Information:
    Title
    Sensitivity and specificity of ultrasound for identifying involved margins
    Description
    accuracy of ultrasound
    Time Frame
    within 2 weeks after surgery
    Title
    Number of patients with an indication for local adjuvant therapy
    Description
    need for local adjuvant treatment
    Time Frame
    within one month after surgery
    Title
    Quality of life assessed by questionnaires at 4 timepoints
    Description
    Influence of treatment on quality of life
    Time Frame
    before surgery, at 4, 8, and 12 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: buccal mucosal squamous cell carcinoma surgical removal under general anesthesia Exclusion Criteria: tumor is not visible on ultrasound as echolucent region
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carleen Adriaansens, MSc
    Phone
    088-7567805
    Email
    c.m.e.m.adriaansens-2@umcutrecht.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rob Noorlag
    Email
    r.noorlag-3@umcutrecht.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Buccal Cancer Resection Ultrasound Guided

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