ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.

Breast Cancer Clinical Trial

— SEED01  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942092
• Other study ID #: 2755
• Status: Recruiting
• Start date: April 26, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: September 30, 2028
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Breast conserving surgery
Breast conserving surgery after lesion's localization with ROLL or magnetic seed

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri SpA	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free-surgical margins	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	Excess breast resection	Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)	6 months
Secondary	Surgery time	Surgery duration	6 months
Secondary	Hospitalization's days	Number of hospitalization's days	6 months
Secondary	Complications	Complications occurred after biopsy or surgery	6 months
Secondary	Reintervention	Reintervention rates	6 months
Secondary	Follow up	5-years follow-up outcomes	5 years after enrollment