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
About this trial
This is an interventional treatment trial for Breast Cancer Stage I focused on measuring breast cancer, microwave ablation, MRI
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
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
NCT ID
NCT05887154
First Posted
December 15, 2022
Last Updated
May 23, 2023
Sponsor
University Medical Center Groningen
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
We'll reach out to this number within 24 hrs