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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called MOLLI, which assists surgeons in locating and removing breast lesions (abnormal tissue) that cannot be felt but are visible on scans. The researchers aim to determine if MOLLI Localization is superior to traditional methods, such as using a wire or a tiny radioactive seed, for guiding breast-conserving surgery. The trial will compare patient outcomes and costs between MOLLI and standard methods. Women advised to undergo surgery for a non-palpable breast lesion might be suitable candidates for this trial.

As an unphased study, this trial provides patients the opportunity to contribute to innovative research that could enhance surgical outcomes and reduce costs.

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 prior data suggests that the MOLLI Guidance System is safe for breast cancer surgery?

Research has shown that the MOLLI guidance system reliably and accurately locates small breast lumps during surgery that cannot be felt by touch. In earlier studies, MOLLI seeds were successfully placed in all cases, with most positioned close to or within the target area.

The MOLLI system aids surgeons in locating these small breast lumps using a magnetic seed and a special probe. Testing has proven its effectiveness in guiding surgical operations.

Importantly, no major safety concerns have been reported with the MOLLI system. It offers an efficient alternative to traditional methods, which can involve wires or radioactive seeds, and is generally well-tolerated by patients.

Overall, these findings suggest that the MOLLI system is a safe option for those considering breast-conserving surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MOLLI Guidance System is unique because it offers a new way to locate breast cancer lesions during surgery. Unlike traditional methods like wire-guided localization (WGL) or radioactive seed localization (RSL), which involve implanting wires or radioactive seeds, MOLLI uses a magnetic seed and a specialized detection system. This approach aims to simplify the process and potentially improve accuracy during surgery. Researchers are excited because this could mean less discomfort for patients and more precise removal of cancerous tissue.

What evidence suggests that the MOLLI Guidance System is effective for breast cancer surgery?

Research has shown that the MOLLI guidance system, available to participants in this trial, reliably and precisely marks and locates hard-to-feel breast lumps during surgery. In studies, the device accurately identified the targeted areas almost every time. Additionally, only 12% of surgeries required extra tissue removal due to cancer cells at the edge of the removed tissue, a relatively low percentage. Although further research is necessary, these early findings suggest that MOLLI could enhance the outcomes of breast-conserving surgery compared to traditional methods, which are being tested in another arm of this trial. ^{1 3 4 6 7}

Who Is on the Research Team?

Nicole Look Hong, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6997262/

Results of a phase I, non-randomized study evaluating ... The MOLLI guidance system is a reliable and accurate method for intraoperative localization of non-palpable breast lesions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04893421

Magnetic Occult Lesion Localization Instrument (MOLLI ... The overall objective of this study is to evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care approaches. Detailed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977621003660

Preoperative non-palpable breast lesion localization, ... Positioning and localization of reflectors' is nearly of the 100% rate of success. Overall, positive margins rates were 12% (8–17%).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31754951/

Results of a phase I, non-randomized study evaluating ... Conclusions: The MOLLI guidance system is a reliable and accurate method for intraoperative localization of non-palpable breast lesions. Further evaluation of ...

5. archbreastcancer.com archbreastcancer.com/index.php/abc/article/download/1117/1075/13691

Image-Guided Pre-Operative Magnetic Seed Localization ... Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument. (MOLLI) for excision of non-palpable ...

6. archbreastcancer.com archbreastcancer.com/index.php/abc/article/view/1117

Image-Guided Pre-Operative Magnetic Seed Localization ... MOLLI seeds were successfully placed in 100% of cases, with 76% within or adjacent to the lesion. Of the excised lesions, 70.3% were malignant, ...

7. ajronline.org ajronline.org/doi/10.2214/AJR.18.20195

Evaluation of a Ferromagnetic Marker Technology for ... CONCLUSION. The MOLLI system offers an accurate and efficient alternative lesion localization method for nonpalpable breast lesions.