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Trial Title:
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
NCT ID:
NCT05942118
Condition:
Breast Cancer
Conditions: Keywords:
Non-palpable breast lesion
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Breast conservative surgery
Description:
Every patients with non-palpable breast lesion will undergo to conservative breast
surgery after lesion's localization
Arm group label:
ROLL
Arm group label:
SEED
Summary:
Several localization techniques are now in use for localization of non-palpable breast
lesions. Several studies have compared wire guided localization (WGL), which has been for
years the gold standard for non-palpable breast lesions' localization, with more modern
techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques,
which appear to be comparable to the WGL in terms of safe surgical resection, while
overcoming limitations associated with logistic difficulties and patient discomfort.
There is still limited data in literature on the comparative effectiveness of these
modern techniques, and there is no strong evidence that one is superior to the others. In
particular, no randomized trials of comparison between ROLL and magnetic seed
localization are currently available. The aim of this randomized study is to compare ROLL
with magnetic seed to assess their efficacy for non-palpable breast lesions'
localization.
Criteria for eligibility:
Study pop:
Breast cancer patients with non-palpable lesions candidated for surgery
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Female;
- Non-palpable breast lesions;
- Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
- Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or
malignant lesion (B4-B5 or C4-C5);
- Written informed consent.
Exclusion Criteria:
- Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle
aspiration (C2);
- Clinically palpable breast lesion;
- Breast lesion localization for planned neoadjuvant chemotherapy.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituti Clinici Scientifici Maugeri SpA
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Corsi, Professor
Phone:
0382592272
Email:
fabio.corsi@icsmaugeri.it
Contact backup:
Last name:
Sara Albasini, MsC
Phone:
3497378405
Email:
sara.albasini@icsmaugeri.it
Start date:
May 31, 2023
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Istituti Clinici Scientifici Maugeri SpA
Agency class:
Other
Source:
Istituti Clinici Scientifici Maugeri SpA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942118
