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MOLLI Guidance System for Breast Cancer (MOLLI Trial)

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

MOLLI Trial Summary

This trial is comparing the outcomes of a new breast cancer surgery instrument (MOLLI) to the standard of care (wire-guided localization or radioactive seed localization for BCS).

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.Check my eligibility

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.See study design

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.

MOLLI Trial 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.

MOLLI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MOLLI Localization Success Rate

Secondary outcome measures

Anxiety with Radiation

Cost-effectiveness of MOLLI

Duration of Excision

+5 more

MOLLI 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

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

657 Previous Clinical Trials

1,551,270 Total Patients Enrolled

30 Trials studying Breast Cancer

16,896 Patients Enrolled for Breast Cancer

Princess Margaret Hospital, CanadaOTHER

119 Previous Clinical Trials

39,018 Total Patients Enrolled

12 Trials studying Breast Cancer

22,847 Patients Enrolled for Breast Cancer

North York General HospitalOTHER

20 Previous Clinical Trials

8,715 Total Patients Enrolled

Media Library

MOLLI Localization (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04893421 — N/A

Breast Cancer Research Study Groups: Standard of Care WGS or RSL, MOLLI Localization

Breast Cancer Clinical Trial 2023: MOLLI Localization Highlights & Side Effects. Trial Name: NCT04893421 — N/A

MOLLI Localization (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893421 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment of participants for this clinical trial?

"Affirmative, the information on clinicaltrials.gov verifies that this trial is actively enrolling participants. The study was launched on May 16th 2021 and recently modified for a second time in September 2021, with an aim to recruit 207 individuals from one site."

Answered by AI

Are medical professionals currently seeking participants for this experiment?

"As reported on clinicaltrials.gov this medical trial is recruiting patients. It was initially advertised on May 16th 2021, with the latest editing to occur on September 20th of that same year."

Answered by AI

Recent research and studies

Breast Cancer Research and TreatmentJournal

Results of a Phase I, Non-randomized Study Evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for Excision of Non-palpable Breast Lesions

Look Hong, Nicole, Frances C. Wright, Mark Semple, Alexandru M. Nicolae, and Ananth Ravi. 2019. “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 Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-019-05499-z.

clinicaltrials.govStudy

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

Nicole Look Hong 2021. "Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04893421.