From 2016–2018 our team at the Odette Cancer Center, Sunnybrook Health Sciences Center, engineered, developed and tested a novel approach to localizing non-palpable lesions during breast conserving surgery – The Magnetic Occult Lesion Instrument (MOLLI).

Using support from the AFP innovation grant, the MOLLI team created hardware and software components – maximizing ergonomics of the marker and detection probe, and designing an intuitive user interface and auditory response system.   With continuous feedback from clinicians,  MOLLI is sure to be clinically adaptable.   Technical optimization and a first-in-human clinical trial are completed.  Trial results were presented at the 2019 American Society of Breast Surgeons annual meeting .  The next step is a multi-center registry study across several Canadian and American institutions.

The AFP grant provided requisite funds to test and benchmark MOLLI in pre-clinical and laboratory settings, and critically evaluate its use in a first-in-human pilot clinical trial.

Pre-Clinical MOLLI Testing:
 MOLLI was evaluated using phantoms mimicking clinical use to evaluate system accuracy, depth sensitivity, ability to bracket, and susceptibility to metal surgical instruments. Key findings include an industry-leading depth of marker detection of 8 cm from the skin surface, the ability to differentiate two markers placed as close as 1 cm apart, lack of interference from standard steel surgical equipment, and accurate measurement of distance from the probe tip to marker. Ergonomics of the marker and probes, as well as design of an intuitive user interface and auditory response was optimized with continuous feedback from clinicians (surgeons /radiologists) that treat a high volume of patients, to ensure that the system in clinically adaptable and appropriate.The pre-clinical bench-top characterization of the MOLLI guidance system has been accepted for publication in the American Journal of Roentgenology.

Phase I Clinical Testing: To validate MOLLI technology, an ethics-approved, phase I, non-randomized study at our center was undertaken to evaluate the clinical feasibility of using MOLLI for intraoperative localization of non-palpable breast lesions. Efficacy was measured using patient and clinician reported outcomes and pathological analysis post procedure. 20 patients were successfully localized with no positive margins indicating reliability and accuracy. Surgeons and radiologists endorsed ease of use. Results from this trial were presented at an international forum and are currently being published. The next step is to compare MOLLI to current standards of care and to evaluate system cost effectiveness.