Clinical trial · Interventional
Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
A Registry Study Evaluating the Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOLLI Localization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care WGS or RSL
- description
- Patients will undergo the institutional standard of care approach (WGS or RSL) for BCS. For WGL, a hooked wire will be implanted to mark the center or outer edges of the lesion under imaging guidance. For RSL, patients will be implanted with a radioactive seed using an impregnated needle under imaging guidance. A special handheld probe will be used to find the radioactive seed during the lumpectomy surgery.
- type
- EXPERIMENTAL
- label
- MOLLI Localization
- description
- 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.
- interventionNames
- Device: MOLLI Localization
Primary outcomes (1)
- measure
- MOLLI Localization Success Rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18 years or older with histologically confirmed unifocal breast lesion and identified as a candidate for BCS, this includes patients with high-risk, premalignant (eg. ductal carcinoma in-situ), or malignant (eg. invasive ductal carcinoma) lesions * Lesions must be non-palpable and require pre-operative localization for surgical guidance * Lesions must be visible as determined by preoperative breast mammogram and / or ultrasound imaging. Pre-operative MRI is at the discretion of the treating surgeon. Exclusion Criteria: * Biologically male patients * Locally advanced malignant breast cancer * Any absolute contraindications to BCS * Pregnancy or lactation * Existing allergy to metallic seed materials * Patients requiring MRI after MOLLI seed placement
References
Publications (1)
- BACKGROUNDLook Hong N, Wright FC, Semple M, Nicolae AM, Ravi A. Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions. Breast Cancer Res Treat. 2020 Feb;179(3):671-676. doi: 10.1007/s10549-019-05499-z. Epub 2019 Nov 21. PMID 31754951