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

  • STATUS
    Recruiting
  • End date
    Apr 27, 2023
  • participants needed
    170
  • sponsor
    Radboud University
Updated on 27 September 2021
carcinoma
breast carcinoma
invasive breast cancer
lumpectomy
sentinel node
breast-conserving surgery
magnetic resonance imaging of breast

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.

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, cancer, breast, breast carcinoma
Treatment Vacuum assisted biopsy, conventional lumpectomy
Clinical Study IdentifierNCT04107636
SponsorRadboud University
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female sex
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note