NCT05942092: SEED01

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

Active, enrolled Last updated 23 February 2026

What this trial tests

trial testing Breast conserving surgery in Breast Cancer in 1,400 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 April 2023

Primary endpoint
30 December 2025

30 September 2028

Quick facts

Lead sponsor	Istituti Clinici Scientifici Maugeri SpA
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,400
Start date	26 April 2023
Primary completion	30 December 2025
Estimated completion	30 September 2028
Sites	1 location across Italy

Drugs / interventions tested

• Breast conserving surgery

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

Adults 18 to 85, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.