Vacuum-assisted biopsy for small breast lesions
Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast
This study is testing if a new type of biopsy called vacuum-assisted excisional biopsy can effectively remove small breast lesions linked to atypical ductal hyperplasia and low-intermediate grade ductal carcinoma in situ.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05932758 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to evaluate the effectiveness of vacuum-assisted excisional biopsy (VAE) in completely removing small breast lesions associated with Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS). Patients with suspicious breast lesions will be enrolled based on specific criteria, including lesion size and biopsy results. The study will involve a randomized approach where patients will either complete the biopsy after an initial sampling or undergo additional sampling to ensure complete removal of the lesion. The goal is to assess the potential benefits of VAE compared to traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates include women with suspicious breast lesions (BIRADS >3) that are 15 mm or smaller and have biopsy results indicating ADH or low-intermediate grade DCIS.
Not a fit: Patients with psychiatric or addictive disorders that impair their ability to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgery and improve the quality of life for patients with small breast lesions.
How similar studies have performed: Other studies have shown promising results with vacuum-assisted techniques for breast lesions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with suspicious breast lesions (BIRADS \>3) * Patients with a lesion \<= of 15mm. * Capable and willing to comply the specific informed consent form * Patients with ADH biopsy results or low intermediate-grade DCIS * Patients who will undergo surgery Exclusion Criteria: - Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Where this trial is running
Milan
- Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Nicosia, MD — European Institute of Oncology IRCCS
- Study coordinator: Luca Nicosia, MD
- Email: luca.nicosia@ieo.it
- Phone: +390294372449
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.