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Trial Title:
ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.
NCT ID:
NCT05942092
Condition:
Breast Cancer
Conditions: Keywords:
Non-palpable breast lesion
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Breast conserving surgery
Description:
Breast conserving surgery after lesion's localization with ROLL or magnetic seed
Arm group label:
ROLL
Arm group label:
SEED
Summary:
Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected
by early breast lesions. Screening programmes led to an increase of impalpable breast
lesion detection rates. These patients are often eligible for BCS and an accurate
preoperative localization technique for the detection of the lesion is required in order
to guarantee a safe surgical excision.
The primary goal of BCS is to obtain a complete resection of the tumor with disease-free
surgical margins. The presence of tumor on surgical margins on postoperative histological
examination of the specimen increases the risk of local recurrence and it requires a
surgical re-excision. For all these reasons different techniques for localization of
occult breast lesions have been developed over time. Since '70s, the wire guided
localization (WGL) technique has represented the gold standard technique; however, it has
several limitations such as wire migration or fracture and patient's referred discomfort
related to wire placement. Other techniques have been proposed such as the ROLL and
magnetic seeds.
The ROLL consists of the injection of a radioactive substance into the breast lesion and
the localization during surgery is allowed by using a handheld gamma probe. Limitations
of this technique are represented by the need of radioactive injection the day before
surgery with subsequent longer hospitalizations and the possible spread of the
radioactive substance into breast tissue leading to larger resections.
The latest technological evolution is represented by magnetic seeds, small devices
deployed into the lesion even up to more than 30 days before surgery and identified with
a specific magnetic probe during surgery.
Currently there are several studies of comparison between the WGL and the more modern
techniques. All of these data claim the effectiveness of the new "wire-free" methodics
ensuring a safe surgical resection with tumor-free margins and, in some cases, a better
aesthetic result.
Studies of comparison between the modern techniques are limited. There is no scientific
evidence of the superiority of magnetic seeds compared to ROLL.
The aim of this retrospective study is to compare ROLL with magnetic seed to assess their
efficacy in the localization of non-palpable breast lesions.
Criteria for eligibility:
Study pop:
Breast cancer women with non-palpable lesions
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Female patients between 18 and 85 years who underwent to breast conservative surgery
for non-palpable occult breast lesions;
- Intraoperative localization of breast lesion with ROLL or magnetic seed;
- Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or
malignant lesion (B4-B5 or C4-C5).
Exclusion Criteria:
- B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration.
- Breast tumor localization with clip for neoadjuvant chemotherapy.
Gender:
Female
Gender based:
Yes
Gender description:
Breast cancer is gender based
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:
April 26, 2023
Completion date:
September 30, 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/NCT05942092
