Minimally invasive removal of small breast cancers using ultrasound-guided biopsy
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
This study is testing if a special ultrasound-guided technique can safely remove small breast cancers in women to improve their treatment experience and results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT04107636 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of completely excising small breast cancers (≤15 mm) using a Vacuum Assisted Biopsy (VAB) system under ultrasound guidance. Conducted in multiple centers, it aims to treat 170 women with non-lobular invasive carcinomas who meet specific criteria, including no evidence of more extensive disease. The goal is to improve outpatient treatment options, cosmetic outcomes, and quality of life for women with small breast cancers.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with non-lobular invasive breast carcinoma ≤15 mm visible on ultrasound.
Not a fit: Patients with extensive disease, poor ultrasound visibility, or those who are male or under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow for outpatient treatment of small breast cancers, enhancing patient comfort and recovery.
How similar studies have performed: While similar minimally invasive techniques have shown promise, this specific approach using VAB under ultrasound guidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Ritse Mann, PhD — Radboud University Medical Center
- Study coordinator: Wendelien Sanderink, MSc
- Email: wendelien.sanderink@radboudumc.nl
- Phone: 0031243614546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.