NCT04107636

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

4.3 years

First QC Date

June 13, 2019

Last Update Submit

July 22, 2025

Conditions

Breast Cancer

Keywords

Minimal invasiveBiopsy

Outcome Measures

Primary Outcomes (1)

  • Frequency of successful complete tumor excision by the VAB system

    Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.

    Through study completion, an average of two months

Secondary Outcomes (6)

  • Incidence of successful complete resection of the tumor based upon imaging related features using a questionnaire filled in by a radiologist.

    2 years

  • Incidence of successful complete resection of the tumor based upon patient related features using a questionnaire filled in by the patient.

    2 years

  • 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.

    2 years

  • Incidence of successful complete resection of the tumor based upon histopathological features from the VAB specimens using a questionnaire filled in by a pathologist.

    2 years

  • Incidence of successful complete resection of the tumor based upon histopathological features from the surgical specimens using a questionnaire filled in by a pathologist.

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

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.

Procedure: Vacuum assisted biopsyProcedure: conventional lumpectomy

Interventions

Vacuum assisted biopsyPROCEDURE

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.

Assigned Interventions
conventional lumpectomyPROCEDURE

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.

Assigned Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ritse Mann, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendelien Sanderink, MSc

CONTACT

0031243614546wendelien.sanderink@radboudumc.nl

Ritse Mann, PhD

CONTACT

0031243614546ritse.mann@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

September 27, 2019

Study Start

August 2, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

NL(1)