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Non Surgical Treatment (Microwave Ablation) of Breast Cancer (MASTER)

Primary Purpose

Breast Cancer Stage I

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Stage I focused on measuring breast cancer, microwave ablation, MRI

Eligibility Criteria

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

Inclusion Criteria: age should be 18 years and older a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements without mammographic or MRI evidence of extensive disease no involved lymph nodes on ultrasound and MRI scan. Exclusion Criteria: more than one breast tumor, (lymph node) metastases breast implants indication for neoadjuvant chemotherapy. pacemaker, pregnant breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Microwave ablation

    Arm Description

    Each patient will undergo Microwave ablation of breast tumor before the standard clinical care (surgery)

    Outcomes

    Primary Outcome Measures

    MWA followed by MRI in breast tumors
    MWA will be succesfull if less than 20% of the patients has residual disease

    Secondary Outcome Measures

    Cosmetic outcome
    Breast Q questionaire
    breast cancer recurrence fear
    Lerman Breast Cancer Worry scal
    Quality of life
    EuroQol 5D5L

    Full Information

    First Posted
    December 15, 2022
    Last Updated
    May 23, 2023
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887154
    Brief Title
    Non Surgical Treatment (Microwave Ablation) of Breast Cancer
    Acronym
    MASTER
    Official Title
    Minimal Invasive Microwave Ablation in Early Stage breaST cancER, a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size <2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. The standard treatment for stage 1 breast cancer is breast conserving surgery (BCS), sentinel lymph node procedure (SLNP) and additional radiotherapy. This standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. However, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. To reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions. Patients with a tumor size<2 cm will undergo ultra guided microwave ablation (MWA) with local anesthesia. After a small incision 2-3 millimeters, an MWA electrode is placed at the end of the tumor with ultrasound guidance. The microwaves in MWA create heat around the needle and destroy the cancer cells. There are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. Furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. A post procedural MRI (after ablation) can determine whether the ablation procedure of the tumor volume is complete. The purpose of this study is to assess whether minimally invasive microwave ablation (MWA) followed by postprocedural MRI scan can be an alternative treatment for breast surgery in early stage breast cancer. Is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with MWA comparable or better compared to patients treated with breast surgery?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Stage I
    Keywords
    breast cancer, microwave ablation, MRI

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Microwave ablation
    Arm Type
    Other
    Arm Description
    Each patient will undergo Microwave ablation of breast tumor before the standard clinical care (surgery)
    Intervention Type
    Device
    Intervention Name(s)
    Microwave ablation
    Intervention Description
    microwave ablation
    Primary Outcome Measure Information:
    Title
    MWA followed by MRI in breast tumors
    Description
    MWA will be succesfull if less than 20% of the patients has residual disease
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Cosmetic outcome
    Description
    Breast Q questionaire
    Time Frame
    Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
    Title
    breast cancer recurrence fear
    Description
    Lerman Breast Cancer Worry scal
    Time Frame
    Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery
    Title
    Quality of life
    Description
    EuroQol 5D5L
    Time Frame
    Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age should be 18 years and older a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements without mammographic or MRI evidence of extensive disease no involved lymph nodes on ultrasound and MRI scan. Exclusion Criteria: more than one breast tumor, (lymph node) metastases breast implants indication for neoadjuvant chemotherapy. pacemaker, pregnant breastfeeding

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Non Surgical Treatment (Microwave Ablation) of Breast Cancer

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