Excisional Vacuum-Assisted Breast Biopsy

Ductal Carcinoma in Situ Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932758
• Other study ID #: IEO 1856
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2023
• Source: European Institute of Oncology
• Contact: Luca Nicosia, MD
• Phone: +390294372449
• Email: luca.nicosia[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Ductal Hyperplasia
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ
• Hyperplasia

Intervention

Procedure:
• Vacuum-assisted excisional biopsy
at least 4g of tissue sampled (excisional biopsy)
• Not excisional biopsy
biopsy with less than 4 g of tissue sampled

Locations

Country	Name	City	State
Italy	Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS	Milan

Sponsors (2)

Lead Sponsor	Collaborator
European Institute of Oncology	Ministero della Salute, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete removal of lesion	Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups	6 months