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

Breast Cancer Clinical Trial

— SEED02  

Official title:

A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942118
• Other study ID #: 2778
• Status: Recruiting
• Start date: May 31, 2023
• Est. completion date: May 31, 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Breast conservative surgery
Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization

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 disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).	3 years
Secondary	Excess breast resection	Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume	3 years
Secondary	Surgery Time	Surgery duration (hours)	3 years
Secondary	Hospitalization days	Number of hospitalization's days	3 years
Secondary	Complications	Complications occurred after biopsy or surgery	3 years
Secondary	Reintervention	Reintervention rates	3 years
Secondary	Cost-effectiveness analysis	Cost-effectiveness analysis in different subgroups	3 years
Secondary	Follow up	5-years follow-up outcomes	5 years after enrollment