Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study. (SEED02)

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Breast conservative surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05942118

2778

Details and patient eligibility

About

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.

Enrollment: 262 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

262 participants in 2 patient groups

ROLL

Description:

Prior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node.

Treatment:

Procedure: Breast conservative surgery

SEED

Description:

During diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye

Treatment:

Procedure: Breast conservative surgery