ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques. (SEED01)
A Retrospective Multicentric Clinical Study Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed in the Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Lombardy
-
Pavia, Lombardy, Italy, 27100
- Istituti Clinici Scientifici Maugeri SpA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ROLL
|
Breast conserving surgery after lesion's localization with ROLL or magnetic seed
|
|
SEED
|
Breast conserving surgery after lesion's localization with ROLL or magnetic seed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Free-surgical margins
Time Frame: 6 months
|
Number of surgical procedures in which surgical margins are tumor disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Excess breast resection
Time Frame: 6 months
|
Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)
|
6 months
|
|
Surgery time
Time Frame: 6 months
|
Surgery duration
|
6 months
|
|
Reintervention
Time Frame: 6 months
|
Reintervention rates
|
6 months
|
|
Follow up
Time Frame: 5 years after enrollment
|
5-years follow-up outcomes
|
5 years after enrollment
|
|
Hospitalization's days
Time Frame: 6 months
|
Number of hospitalization's days
|
6 months
|
|
Complications
Time Frame: 6 months
|
Complications occurred after biopsy or surgery
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2755
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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