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

NCT04893421 | Completed DMC

• 1 other identifier: 159-2019
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non-palpable lesion; Localization; Lumpectomy; Breast-Conserving Surgery; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• MOLLI Localization Success Rate

  To determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance compared to standard of care approaches.

  Day 3 (during surgical excision)

Secondary Outcomes (8)

• Specimen Margin Positivity

  Day 30

• Re-excision rates

  Day 30

• Duration of Excision

  Day 3 (during surgery)

• Duration of Implantation

  Day 1 (localization)

• Cost-effectiveness of MOLLI

  Day 1 (localization) and Day 3 (post surgery)

Study Arms (2)

Standard of Care WGS or RSL

NO INTERVENTION

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.

MOLLI Localization

EXPERIMENTAL

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.

Device: MOLLI Localization

Interventions

MOLLI Localization DEVICE

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.

MOLLI Localization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Princess Margaret Hospital, Canada: collaborator
• North York General Hospital: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N-3M5, Canada

Location

Related Publications (1)

• Look 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nicole Look Hong, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncologist

Model Details: At each site, the first cohort of 25 participants will be treated with the standard of care approach (WGS or RSL) and the subsequent cohort of 25 participants will be treated with MOLLI.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 16, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)