Excisional Vacuum-Assisted Breast Biopsy

Not Applicable

Recruiting

• Conditions: Ductal Carcinoma in Situ; Atypical Ductal Hyperplasia
• Interventions: Procedure: Not excisional biopsy; Procedure: Vacuum-assisted excisional biopsy

• Registration Number: NCT05932758
• Lead Sponsor: European Institute of Oncology

Brief Summary

The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).

Detailed Description

Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.

Patients with suspicious breast lesions (BIRADS\>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.

The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Status Verified: 2023-07
• Study First Posted: 2023-07-06
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no excisional biopsy	Not excisional biopsy	Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)
excisional biosy	Vacuum-assisted excisional biopsy	Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)

Primary Outcome Measures

Name	Time	Method
Percentage of patients with complete removal of lesion	6 months	Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups

Trial Locations

Locations (1)

Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS; 🇮🇹 Milan, Italy