MELODY: MEthods for LOcalization of Different Types of Breast Lesions

Sponsor

European Breast Cancer Reseach Association of Surgical Trialists (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05559411

Collaborator

iBRA-NET (Other)

7,416

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

7416 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Wire-guided Localization
Intraoperative Ultrasound
Magnetic Localization
Radar Reflector Localization
Radiofrequency Localization
Radioactive Localization
Ink Localization

Outcome Measures

Primary Outcome Measures

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) [2 years]
Negative resection margin rates (defined as lesion removal with no invasive or non-invasive carcinoma on ink) at first surgery [2 years]
Number of study participants with a negative resection margin, divided by the number of all study participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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