Status:
COMPLETED
Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Princess Margaret Hospital, Canada
North York General Hospital
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The proposed trial is a non-randomized, multi-center, sequential arm registry evaluating clinical, and health economic outcomes following treatment with the Magnetic Occult Lesion Localization Instrum...
Detailed Description
BACKGROUND INFORMATION In contemporary breast cancer management, more than 70% of breast cancer patients are eligible for - and select - breast-conserving therapy (BCS). However, issues with cosmesis...
Eligibility Criteria
Inclusion
- Women 18 years or older with histologically confirmed unifocal breast lesion 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 visible as determined by preoperative breast mammogram and / or ultrasound imaging. Pre-operative MRI is at the discretion of the treating surgeon.
Exclusion
- Biologically male patients
- Locally advanced malignant breast cancer
- Any absolute contraindications to BCS
- Pregnancy or lactation
- Existing allergy to metallic seed materials
- Patients requiring MRI after MOLLI seed placement
Key Trial Info
Start Date :
May 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04893421
Start Date
May 16 2021
End Date
June 30 2024
Last Update
December 2 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N-3M5