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MEthods for LOcalization of Different Types of Breast Lesions

Study acronym: MELODY
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2025 → Dec 2027
See other at-risk trials from European Breast Cancer Research Association of Surgical Trialists

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Dec 2025 to Dec 2027
    • Primary endpoints: details revised at 1 of 2 entries
    • Study completion pushed from Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 15 words
  2. Minor Study arms: 7 to 8v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jan 2025 to Dec 2025
    • Study sites: 0 to 1
    • Study completion date: Jul 2025 to Dec 2026
    • Start date changed from estimate of Dec 2022 to Jan 1, 2023
  5. Minor Enrollment target: 7168 to 7416v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05559411
Lead Sponsor European Breast Cancer Research Association of Surgical Trialists
Collaborators: iBRA-NET
Conditions
(from sponsor)
Breast Cancer
Related terms Breast Neoplasms
Enrollment 7,416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov