NCT05932758

Excisional Vacuum-Assisted Breast Biopsy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atypical Ductal Hyperplasia
• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
PROCEDURE	Vacuum-assisted excisional biopsy	at least 4g of tissue sampled (excisional biopsy)
PROCEDURE	Not excisional biopsy	biopsy with less than 4 g of tissue sampled

Timeline

• Start date: 2023-01-17
• Primary completion: 2025-04-30
• Completion: 2025-07-31
• First posted: 2023-07-06
• Last updated: 2023-07-21

Locations

1 site across 1 country: Italy