What side effects are associated with this type of intervention?

Common treatments for breast cancer, including breast-conserving surgery (BCS) and sentinel lymph node (SLN) biopsy, can have several side effects. Surgical procedures may lead to pain, infection, hematoma, and changes in breast shape or appearance. Radiotherapy can cause skin irritation, fatigue, and, in some cases, long-term changes such as fibrosis or lymphedema. Chemotherapy often results in side effects like nausea, hair loss, fatigue, and increased risk of infection. Magnetic localization methods, such as those studied in the MOLLI trial, are generally well-tolerated but can still involve minor discomfort or localized pain at the insertion site.

What other types of research exist?

Promising novel alternatives to MOLLI for breast cancer patients include Radioguided Occult Lesion Localization (ROLL) and the use of lesion positioning stickers. ROLL has shown efficacy and accuracy in localizing non-palpable breast lesions, while lesion positioning stickers offer a new method for surface localization before biopsy.

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Device

MOLLI Guidance System for Breast Cancer (MOLLI Trial)

Q: What prior FDA approvals exist?

The FDA has approved several methods for the localization of non-palpable breast lesions, including Wire-Guided Localization (WGL) and Radioactive Seed Localization (RSL). These methods are used to accurately locate and excise breast tumors that are not palpable. The Magnetic Occult Lesion Localization Instrument (MOLLI) is a newer, approved technology that offers a magnetic method for localizing breast lesions, providing an alternative to WGL and RSL. This method is well-tolerated by patients and avoids some disadvantages associated with traditional localization techniques.

N/A

Waitlist Available

Led By Nicole Look Hong, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lesions must be non-palpable and require pre-operative localization for surgical guidance

Women 18 years or older with histologically confirmed unifocal breast lesion and identified as a candidate for BCS, including patients with high-risk, premalignant (e.g. ductal carcinoma in-situ) or malignant (e.g. invasive ductal carcinoma) lesions

Must not have

Biologically male patients

Any absolute contraindications to BCS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 (baseline), day 1 (localization) and day 30 (1 month follow-up)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of MOLLI aren't detailed here, typical risks may include discomfort at the localization site, minor bleeding or bruising. Allergic reactions could occur in patients sensitive to metallic materials used in the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am biologically male.

Select...

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

Select...

My breast cancer has spread to nearby tissues but not distant parts of the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 (baseline), day 1 (localization) and day 30 (1 month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 (baseline), day 1 (localization) and day 30 (1 month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (baseline), day 1 (localization) and day 30 (1 month follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MOLLI Localization Success Rate

Secondary study objectives

Anxiety with Radiation

Cost-effectiveness of MOLLI

Duration of Excision

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MOLLI LocalizationExperimental Treatment1 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 RSLActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MOLLI Localization

2018

N/A

~70

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments typically include surgery, radiation therapy, and systemic treatments such as chemotherapy, hormone therapy, and targeted therapy. Surgical options, like lumpectomy or mastectomy, aim to remove the tumor and surrounding tissue. Radiation therapy uses high-energy rays to destroy cancer cells and reduce recurrence risk. Systemic treatments work by targeting cancer cells throughout the body: chemotherapy kills rapidly dividing cells, hormone therapy blocks hormones that fuel certain cancers, and targeted therapy attacks specific molecules involved in cancer growth. Techniques like the Magnetic Occult Lesion Localization Instrument (MOLLI) are crucial for accurately locating non-palpable lesions, ensuring precise surgical removal, and minimizing healthy tissue damage, which is vital for effective treatment and better patient outcomes.

Application value of a new lesion positioning stickers in breast lesion surface localization.Magnetic sentinel lymph node biopsy in a murine tumour model.