Clinical trial NCT05932758: Excisional Vacuum-Assisted Breast Biopsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atypical Ductal Hyperplasia
Ductal Carcinoma in Situ
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2023-07-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients with complete removal of lesion
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
Study officials:
affiliation: European Institute of Oncology IRCCS
name: Luca Nicosia, MD
role: PRINCIPAL_INVESTIGATOR
References: