Clinical trial NCT05559411: MEthods for LOcalization of Different Types of Breast Lesions
Official title: A Prospective Non-interventional Multicenter Cohort Study to Evaluate Different Imaging-guided Methods for Localization of Non-palpable Malignant Breast Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
non-palpable breast lesion
localization technique
localization device
intraoperative ultrasound
patient-reported outcome
Lead sponsor: European Breast Cancer Reseach Association of Surgical Trialists
Sponsor class: NETWORK
Collaborators: name: iBRA-NET
First posted: 2022-09-29
Enrollment: 7416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2 years
measure: Negative resection margin rates (defined as lesion removal with no invasive or non-invasive carcinoma on ink) at first surgery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein Campus Lübeck
Study officials:
References: