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Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance (MINIVAB)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vacuum assisted biopsy
conventional lumpectomy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Minimal invasive, Biopsy

Eligibility Criteria

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

Inclusion Criteria:

  • Female sex.
  • 18 years or older.
  • US visible breast cancer.
  • Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US.
  • Willing and able to undergo preoperative breast MRI
  • Able to fill out the questionnaire
  • Able to provide informed consent.

Exclusion Criteria:

  • Male sex.
  • 17 years or younger.
  • No proven invasive breast cancer.
  • Poor US visibility of the breast cancer.
  • Neoadjuvant therapy.
  • Contra-indications to breast MRI or intravenous contrast administration.
  • Unable to fill out the questionnaire
  • Unable to provide informed consent.
  • Patients with breast implants.
  • Pregnancy.
  • Presence of additional malignant lesions at ipsilateral site on MRI.

Sites / Locations

  • RadboudumcRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assigned Interventions

Arm Description

First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.

Outcomes

Primary Outcome Measures

Frequency of successful complete tumor excision by the VAB system
Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.

Secondary Outcome Measures

Incidence of successful complete resection of the tumor based upon imaging related features using a questionnaire filled in by a radiologist.
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are imaging related features from mammography, ultrasound and MRI (a.o. breast density, lesion type, shape, (background) enhancement). The questionnaire will be filled in by a radiologist.
Incidence of successful complete resection of the tumor based upon patient related features using a questionnaire filled in by the patient.
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are patient related variables (a.o. age, body mass index, age at menarch, obstetric history, menopause status, history of a benign breast condition, history of ovarian cancer, use of hormone replacement therapy, family history). Patients will be asked to fill out a questionnaire for assessment of breast cancer risk, using the Tyrer-Cuzick (or IBIS) model.
Incidence of successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens using a questionnaire filled in by a pathologist.
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the large core biopsy specimen (a.o. type of cancer, vascular invasion, receptor status, grade). The questionnaire will be filled in by a pathologist.
Incidence of successful complete resection of the tumor based upon histopathological features from the VAB specimens using a questionnaire filled in by a pathologist.
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the VAB specimen (a.o. type of cancer, vascular invasion, receptor status, grade, tubular formation, mitotic count). The questionnaire will be filled in by a pathologist.
Incidence of successful complete resection of the tumor based upon histopathological features from the surgical specimens using a questionnaire filled in by a pathologist.
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the surgical specimen (a.o. type of cancer, vascular invasion, receptor status, grade, tubular formation, mitotic count, tumor satellites). The questionnaire will be filled in by a pathologist.
Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.
In order to analyze the quality-of-life and differences in pain experience after VAE and surgery, patients will be asked to indicate a quality-of-life and pain experience score on the following time points: 1 week after the VAB procedure. 1 week following the surgical procedure. The EORTC QLQ-C30 questionnaire will be used to measure quality-of-life. All of the scales range from 1 to 4 or 1 to 7. A high scale score represents a higher response level. Thus a high score for the quality-of-life represents a high quality-of-life.

Full Information

First Posted
June 13, 2019
Last Updated
January 25, 2023
Sponsor
Radboud University Medical Center
Collaborators
Canisius-Wilhelmina Hospital, The Netherlands Cancer Institute, St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04107636
Brief Title
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
Acronym
MINIVAB
Official Title
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Canisius-Wilhelmina Hospital, The Netherlands Cancer Institute, St. Antonius Hospital

4. Oversight

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

5. Study Description

Brief Summary
This study will assess whether it is feasible to remove small breast cancers completely using the Vacuum Assisted Biopsy (VAB) system System under Ultrasound guidance.
Detailed Description
Rationale: In the Netherlands, ≥7000 women undergo surgery for small breast cancers (T1) every year. In this study, the investigators will evaluate under which conditions it is possible to excise small breast cancers using the vacuum assisted biopsy (VAB) system under ultrasound (US) guidance. When successful, this can allow outpatient treatment of a selection of women with small breast cancers, improving the cosmetic outcome and quality of life. Objective: Our study aim is to assess whether it is feasible to remove small breast cancers completely using the VAB system under US guidance. Study design: This is a multi-centre, translational clinical phase II study in 170 women with cancers ≤15 mm based upon US and MRI measurements, and without mammographic or magnetic resonance imaging (MRI) evidence of more extensive disease (e.g. microcalcifications or non-mass enhancement). Study population: Women with non-lobular invasive carcinomas, ≤15 mm based upon US and MRI measurements, no mammographic evidence of more extensive disease (e.g. microcalcifications or extensive architectural distortion), and sufficient space (roughly ≥6 mm, present or creatable by injection of saline) between the tumor and the dermis, nipple or pectoral muscle, are eligible for this study. Intervention: In 170 women with cancers ≤15 mm based upon US and MRI measurements, and without mammographic evidence of more extensive disease (e.g. microcalcifications), after informed consent has been obtained, patients will be asked to fill out a questionnaire for assessment of breast cancer risk, using the Tyrer-Cuzick (or IBIS) model. First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure. Main study parameters/endpoints: Main endpoint of the study is the incidence of successful complete tumor excision by the VAB system, where successful is defined as having no tumor foci beyond 1 cm from the edge of the VAB cavity in the surgical re-excision specimen. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Our approach allows testing the feasibility of an innovating approach to remove breast cancer, with minimal negative effects or possible complications. The burden from this study to the participating patients is the fact that two procedures are mandatory. This will result in prolonged time from initial diagnosis to end of surgical treatment. Positive study outcomes can pave the way to minimal invasive treatment in a selection of women, presenting with small breast tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Minimal invasive, Biopsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Assigned Interventions
Arm Type
Experimental
Arm Description
First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location. After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.
Intervention Type
Procedure
Intervention Name(s)
Vacuum assisted biopsy
Intervention Description
First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location.
Intervention Type
Procedure
Intervention Name(s)
conventional lumpectomy
Intervention Description
After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.
Primary Outcome Measure Information:
Title
Frequency of successful complete tumor excision by the VAB system
Description
Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.
Time Frame
Through study completion, an average of two months
Secondary Outcome Measure Information:
Title
Incidence of successful complete resection of the tumor based upon imaging related features using a questionnaire filled in by a radiologist.
Description
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are imaging related features from mammography, ultrasound and MRI (a.o. breast density, lesion type, shape, (background) enhancement). The questionnaire will be filled in by a radiologist.
Time Frame
2 years
Title
Incidence of successful complete resection of the tumor based upon patient related features using a questionnaire filled in by the patient.
Description
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are patient related variables (a.o. age, body mass index, age at menarch, obstetric history, menopause status, history of a benign breast condition, history of ovarian cancer, use of hormone replacement therapy, family history). Patients will be asked to fill out a questionnaire for assessment of breast cancer risk, using the Tyrer-Cuzick (or IBIS) model.
Time Frame
2 years
Title
Incidence of successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens using a questionnaire filled in by a pathologist.
Description
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the large core biopsy specimen (a.o. type of cancer, vascular invasion, receptor status, grade). The questionnaire will be filled in by a pathologist.
Time Frame
2 years
Title
Incidence of successful complete resection of the tumor based upon histopathological features from the VAB specimens using a questionnaire filled in by a pathologist.
Description
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the VAB specimen (a.o. type of cancer, vascular invasion, receptor status, grade, tubular formation, mitotic count). The questionnaire will be filled in by a pathologist.
Time Frame
2 years
Title
Incidence of successful complete resection of the tumor based upon histopathological features from the surgical specimens using a questionnaire filled in by a pathologist.
Description
An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after VAB. Factors included in the analysis are histopathological related features from the surgical specimen (a.o. type of cancer, vascular invasion, receptor status, grade, tubular formation, mitotic count, tumor satellites). The questionnaire will be filled in by a pathologist.
Time Frame
2 years
Title
Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.
Description
In order to analyze the quality-of-life and differences in pain experience after VAE and surgery, patients will be asked to indicate a quality-of-life and pain experience score on the following time points: 1 week after the VAB procedure. 1 week following the surgical procedure. The EORTC QLQ-C30 questionnaire will be used to measure quality-of-life. All of the scales range from 1 to 4 or 1 to 7. A high scale score represents a higher response level. Thus a high score for the quality-of-life represents a high quality-of-life.
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female sex. 18 years or older. US visible breast cancer. Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US. Willing and able to undergo preoperative breast MRI Able to fill out the questionnaire Able to provide informed consent. Exclusion Criteria: Male sex. 17 years or younger. No proven invasive breast cancer. Poor US visibility of the breast cancer. Neoadjuvant therapy. Contra-indications to breast MRI or intravenous contrast administration. Unable to fill out the questionnaire Unable to provide informed consent. Patients with breast implants. Pregnancy. Presence of additional malignant lesions at ipsilateral site on MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendelien Sanderink, MSc
Phone
0031243614546
Email
wendelien.sanderink@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Ritse Mann, PhD
Phone
0031243614546
Email
ritse.mann@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritse Mann, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendelien Sanderink, MSc
Email
Wendelien.Sanderink@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Ritse Mann, MD, PhD
Email
Ritse.Mann@radboudumc.nl

12. IPD Sharing Statement

Learn more about this trial

Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance

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