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Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization

NCT04893421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-12-02

No results posted yet for this study

Summary

The proposed trial is a non-randomized, multi-center, sequential arm registry evaluating clinical, and health economic outcomes following treatment with the Magnetic Occult Lesion Localization Instrument (MOLLI), an approved instrument for Breast Conserving Surgery (BCS) in patients with non-palpable lesions. All patients who have an area of concern in the breast and are identified by their physician as good candidates for BCS are eligible to participate. Patients will eventually be enrolled across 3 surgical sites (Sunnybrook Health Sciences Centre - primary site, Princess Margaret Cancer Centre, and North York General Hospital) over a 2 year period. Patient and system-related outcome measures will first be collected using the centre-specific standard of care (Wire-Guided Localization or Radioactive Seed Localization for BCS) to establish a baseline. Subsequently, centers will transition to the MOLLI system, recording corresponding outcomes to be used for temporal comparison. The overall objective of this study is to evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care approaches.

Conditions

  • Breast Neoplasm

Interventions

DEVICE

MOLLI Localization

Patients will be implanted with a MOLLI seed using a specialized introducer needle under imaging guidance. A special handhold probe and detection system will be used intraoperatively to assist in excision.

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • North York General Hospital

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Nicole Look Hong, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-16
Primary Completion
2023-06-30
Completion
2024-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893421 on ClinicalTrials.gov