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Trial Title:
Excisional Vacuum-Assisted Breast Biopsy
NCT ID:
NCT05932758
Condition:
Atypical Ductal Hyperplasia
Ductal Carcinoma in Situ
Conditions: Official terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Hyperplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Vacuum-assisted excisional biopsy
Description:
at least 4g of tissue sampled (excisional biopsy)
Arm group label:
excisional biosy
Intervention type:
Procedure
Intervention name:
Not excisional biopsy
Description:
biopsy with less than 4 g of tissue sampled
Arm group label:
no excisional biopsy
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Nicosia, MD
Start date:
January 17, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Ministero della Salute, Italy
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05932758
