MOLLI Guidance System for Breast Cancer

(MOLLI Trial)

Overseen By Nicole Look Hong, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Male, Advanced cancer, Pregnancy, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

41 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the MOLLI Localization treatment for breast cancer?

Research shows that the MOLLI system, which uses a small magnetic marker to help surgeons find and remove non-palpable breast lesions, is a safe and effective alternative to traditional wire localization methods. It is non-radioactive and can be used without wires, making it a more comfortable option for patients. ^{1 2 3 4 5}

How is the MOLLI Localization treatment different from other treatments for breast cancer?

The MOLLI Localization treatment is unique because it uses a wireless, non-radioactive system to guide the removal of non-palpable breast lesions, unlike traditional methods that often rely on radioactive materials or wires. This makes the procedure less invasive and potentially safer for patients. ^{1 2 4 6 7}

What is the purpose of this trial?

This trial is testing MOLLI, a new tool for breast surgery that uses a magnetic seed to locate tumors. It targets patients with small, hard-to-feel breast tumors who need precise surgery. The magnetic seed helps surgeons find and remove tumors accurately without radiation or wires. The MOLLI system is a new technology for breast cancer localization, involving a small marker to guide the removal of hard-to-feel breast tumors.

Research Team

Nicole Look Hong, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for women over 18 with non-palpable, unifocal breast lesions visible on mammogram or ultrasound and are candidates for Breast Conserving Surgery (BCS). It's not suitable for men, pregnant or breastfeeding women, those with advanced malignant breast cancer, allergies to metallic seed materials, or who need MRI after MOLLI seed placement.

Inclusion Criteria

My breast cancer can be seen on a mammogram or ultrasound.

My cancer cannot be felt by touch and needs imaging for surgery.

I am a woman over 18 with a single breast lesion eligible for surgery.

Exclusion Criteria

I am biologically male.

I have no conditions that absolutely prevent breast-conserving surgery.

Pregnancy or lactation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care Treatment

Participants undergo the institutional standard of care approach (WGS or RSL) for BCS

1 day

1 visit (in-person)

MOLLI Localization Treatment

Participants are treated with the MOLLI system for breast lesion localization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a questionnaire up to 16 weeks post-procedure

16 weeks

1 visit (telephone)

Treatment Details

Interventions

• MOLLI Localization

Trial Overview The study tests the Magnetic Occult Lesion Localization Instrument (MOLLI) against standard localization methods in BCS. Patients at three surgical sites will first undergo traditional wire-guided or radioactive seed localization before switching to MOLLI to compare outcomes.

Participant Groups

Group I: MOLLI Localization Experimental Treatment 1 Intervention

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.

Group II: Standard of Care WGS or RSL Active Control 1 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

North York General Hospital

Collaborator

Trials

22

Recruited

8,800+

Findings from Research

The Breast Cancer Locator™ (BCL) system, which uses supine MRI images to guide tumor localization, was successfully implemented by multiple surgeons across four sites, demonstrating its feasibility and safety.

In a study involving 14 patients, the BCL system achieved a 92% success rate in placing the central localization wire within the tumor, and all excised tumors had negative margins, indicating effective cancer removal without adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in patients with palpable breast cancer. Barth, RJ., Krishnaswamy, V., Rooney, TB., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in patients with palpable breast cancer. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Update on Preoperative Breast Localization. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Ferromagnetic Marker Technology for Intraoperative Localization of Nonpalpable Breast Lesions. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of different localization techniques for non-palpable breast cancer. A systematic review and network meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of Radio-guided Occult Lesion Localization (ROLL) and Magnetic Occult Lesion Localization (MOLL) for Non-palpable Lesions: A Phantom Model Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Needle localization of nonpalpable breast lesions with a portable dual-grid compression system. Work in progress. [2004]