MEthods for LOcalization of Different Types of Breast Lesions (MELODY)

February 15, 2024 updated by: European Breast Cancer Reseach Association of Surgical Trialists

A Prospective Non-interventional Multicenter Cohort Study to Evaluate Different Imaging-guided Methods for Localization of Non-palpable Malignant Breast Lesions

In the last decades, the proportion of breast cancer (BC) patients receiving breast-conserving surgery has increased steadily, reaching 70-80% in developed countries. Since positive resection margins are strongly associated with local recurrence risk, the goal of breast surgery is the complete tumor removal and most national and international guidelines recommend re-operation, either in form of re-excision or mastectomy, until clear margins have been reached. Re-operation rates vary widely, with population-based studies reporting a range of 15-35%, and the necessity for a second surgery can lead to increased patient anxiety, a delay in start of adjuvant treatment, worse cosmetic outcome and increased complication rates and costs. Therefore, re-operation rate has been included as a quality indicator in several countries.

Several imaging-guided techniques have been developed to guide removal of non-palpable breast lesions, the oldest one being preoperative wire placement under ultrasound or mammographic guidance, usually followed by radiography or ultrasound of removed tissue. Newer techniques, such as intraoperative ultrasound (IOUS), radioguided occult lesion localization (ROLL), radioactive seed localization (RSL), radar reflector-localization (RRL), magnetic seed localization (MSL), and radiofrequency identification (RFID) tags have been introduced as an alternative to wire-guided localization (WGL).

To date, comparative data on the rates of successful lesion removal, negative margins, re-operation rate and patient's comfort depending on the localization technique used are limited. Further, since some of these studies were funded by the manufacturer of the marker examined, a potential bias cannot be excluded. In the vast majority of the available studies, the patient's perspective with regard to discomfort and pain level has not been evaluated.

The aim of the proposed study is to comparatively evaluate different imaging-guided localization methods used for surgical removal of malignant breast lesions with regard to oncological safety and patient-reported outcomes.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

7416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Lübeck, Germany
        • Recruiting
        • University Hospital Schleswig-Holstein Campus Lübeck
        • Contact:
          • Maggie Banys-Paluchowski, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Female and male patients with invasive breast cancer or DCIS scheduled for breast-conserving surgery with an imaging-guided localization

Description

Inclusion Criteria:

  • Signed informed consent form
  • Malignant breast lesion requiring breast-conserving surgery and imaging-guided localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and the use of neoadjuvant chemotherapy are allowed)

  • Planned surgical removal of the lesion using one or more of the following imaging-guided localization techniques:

    • Wire-guided localization
    • Intraoperative ultrasound
    • Magnetic localization
    • Radioactive seed localization
    • Radioguided Occult Lesion Localization (ROLL)
    • Radar localization
    • Radiofrequency identification (RFID) tag localization
    • Ink/carbon localization
  • Female / male patients ≥ 18 years old

Exclusion Criteria:

  • Patients not suitable for surgical treatment
  • Patients requiring mastectomy as first surgery
  • Surgical removal without imaging-guided localization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Wire-guided Localization
Intraoperative Ultrasound
Magnetic Localization
Radar Reflector Localization
Radiofrequency Localization
Radioactive Localization
Ink Localization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of intended target lesion and/or marker removal, independent of margin status on final histopathology (number of study participants with intended target lesion and/or marker removal, divided by the number of all study participants)
Time Frame: 2 years
2 years
Negative resection margin rates (defined as lesion removal with no invasive or non-invasive carcinoma on ink) at first surgery
Time Frame: 2 years
Number of study participants with a negative resection margin, divided by the number of all study participants
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Breast Cancer Reseach Association of Surgical Trialists

Collaborators

iBRA-NET

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 18, 2022

First Submitted That Met QC Criteria

September 24, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUBREAST-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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