“Magnetic Occult Lesion Localization and Imaging (MOLLI)”
The proposed trial is a non-randomized, single-arm study examining the technical feasibility and safety of magnetic occult lesion localization and imaging (MOLLI) 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. All patients will undergo standard radioactive seed localization (RSL) for intraoperative surgical guidance concurrently with MOLLI localization. The feasibility trial will take place exclusively at a tertiary care institution (Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada) over a 1-year period. The primary endpoint of this study is to measure the success rate of localizing the MOLLI seed.
Device - MOLLI Localization
All patients will also be implanted with an additional MOLLI seed using a specialized introducer needle. A specialized MOLLI probe will be used to find the magnetic seed during the lumpectomy surgery.
Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial