NCT03660137

Brief Summary

The proposed trial is a non-randomized, single-arm study examining the technical feasibility and safety of magnetic occult lesion localization and imaging (MOLLI) 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. All patients will undergo standard radioactive seed localization (RSL) for intraoperative surgical guidance concurrently with MOLLI localization. The feasibility trial will take place exclusively at a tertiary care institution (Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada) over a 1-year period. The primary endpoint of this study is to measure the success rate of localizing the MOLLI seed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 28, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 22, 2018

Last Update Submit

March 16, 2020

Conditions

Breast Neoplasms

Keywords

Non-palpable lesionLocalizationLumpectomyBreast-Conserving SurgeryBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • MOLLI Localization Success Rate

    The primary goal of this study is to determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance alongside RSL.

    Day 3 post marker implantation (during surgical excision)

Secondary Outcomes (6)

  • Duration of Implantation

    Day 0 (during marker implantation)

  • Specimen Margin Positivity

    Day 30

  • Re-excision rates at 30 days

    Day 30

  • European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life

    Day 0 (baseline), Day 30 (1 month FU)

  • Duration of Excision

    Day 3 (during surgery)

  • +1 more secondary outcomes

Study Arms (1)

MOLLI Localization

EXPERIMENTAL

All patients will be implanted with a MOLLI magnetic seed in addition to the standard-of-care RSL seed. Both systems will be use to localize the respective seeds during the lumpectomy surgery.

Device: MOLLI Localization

Interventions

MOLLI LocalizationDEVICE

All patients will also be implanted with an additional MOLLI seed using a specialized introducer needle. A specialized MOLLI probe will be used to find the magnetic seed during the lumpectomy surgery.

MOLLI Localization

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 18 years or older with histologically confirmed unifocal breast cancer 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 between 1-5 cm in maximum dimensions to facilitate placement of seeds (either radioactive or metallic seeds for RSL or MOLLI procedures, respectively), as determined by preoperative breast mammogram and / or ultrasound imaging. Pre-operative MRI is at the discretion of the treating surgeon
  • The primary lesion must be visible on ultrasound OR mammogram

You may not qualify if:

  • Biologically male patients
  • Multifocal or multi-centric cancer requiring bracketing or multiple resections for complete excision
  • Locally advanced malignant breast cancer
  • Any absolute contraindications to BCS
  • Pregnancy or lactation
  • Unable or unwilling to undergo follow-up at Sunnybrook Health Sciences Centre
  • Prior allergy to magnetic seed components (nickel) or any part of the delivery system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N-3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ananth Ravi, PhD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients will receive both RSL and MOLLI-guided lumpectomy surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Physicist

Study Record Dates

First Submitted

March 22, 2018

First Posted

September 6, 2018

Study Start

May 28, 2018

Primary Completion

June 1, 2019

Study Completion

January 1, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

CA(1)