Clinical trial · Interventional
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
NCT04107636CI-TRIAL-00112703MINIVABcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional lumpectomy | Procedure | — | UNRESOLVED |
| Vacuum assisted biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Assigned Interventions
- 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.
- interventionNames
- Procedure: Vacuum assisted biopsy
- Procedure: conventional lumpectomy
Primary outcomes (1)
- measure
- Frequency of successful complete tumor excision by the VAB system
- timeFrame
- Through study completion, an average of two months
- description
- Successful is defined as 'having no residual (in situ) cancer in the surgical specimen'.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.