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

NCT04107636 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Vacuum assisted biopsy

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.

PROCEDURE

conventional lumpectomy

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.

Sponsors & Collaborators

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • St. Antonius Hospital

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Ritse Mann, PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107636 on ClinicalTrials.gov