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NCT Number: NCT05942118

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast conservative surgery

Procedure

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

Primary outcomes

  1. Free-surgical margins

    Time frame: 3 years

    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).

Secondary outcomes

  1. Excess breast resection

    Time frame: 3 years

    Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume

  2. Surgery Time

    Time frame: 3 years

    Surgery duration (hours)

  3. Hospitalization days

    Time frame: 3 years

    Number of hospitalization's days

  4. Complications

    Time frame: 3 years

    Complications occurred after biopsy or surgery

  5. Reintervention

    Time frame: 3 years

    Reintervention rates

  6. Cost-effectiveness analysis

    Time frame: 3 years

    Cost-effectiveness analysis in different subgroups

  7. Follow up

    Time frame: 5 years after enrollment

    5-years follow-up outcomes

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study 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.

Acronym: SEED02

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jul 12, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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