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Magnetic Occult Lesion Localization and Imaging (MOLLI) (MOLLI)

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ClinicalTrials.gov Identifier: NCT03660137
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ananth Ravi, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Device: MOLLI Localization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will receive both RSL and MOLLI-guided lumpectomy surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MOLLI Localization
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
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.




Primary Outcome Measures :
  1. MOLLI Localization Success Rate [ Time Frame: Day 3 post marker implantation (during surgical excision) ]
    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.


Secondary Outcome Measures :
  1. Duration of Implantation [ Time Frame: Day 0 (during marker implantation) ]
    The duration of MOLLI marker implantation as carried out by the radiologist.

  2. Specimen Margin Positivity [ Time Frame: Day 30 ]
    As reported by anatomical pathology, this metric will evaluate if the excised specimen has negative margins or positive margins.

  3. Re-excision rates at 30 days [ Time Frame: Day 30 ]
    Follow-up will determine if patients required a re-excision / re-operation after determination of positive margin status.

  4. European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life [ Time Frame: Day 0 (baseline), Day 30 (1 month FU) ]
    EQ5D will evaluate overall quality of life pre- and post-MOLLI surgery. Five questions will be evaluated on a 3 point scale (1 being the worst, 3 being the best). Evaluations will occur prior to implantation and approximately 1 month following surgical excision. The lowest score achievable is 5, the highest score achievable is 15.

  5. Duration of Excision [ Time Frame: Day 3 (during surgery) ]
    The time required to perform surgical excision of the lesion and MOLLI marker.

  6. European Quality-of-Life Visual Analogue Scale (EQVAS) questionnaire to evaluate quality-of-life [ Time Frame: Day 0 (baseline), Day 30 (1 month FU) ]
    EQVAS will evaluate overall quality of life pre- and post-MOLLI surgery. Patients will be asked to rank their overall health on a scale from 0 to 100 (0 being the worst, 100 being the best). The lowest total score is 0, the highest achievable total score is 100.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660137


Contacts
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Contact: Ananth Ravi, PhD 416-480-6100 ext 1092 ananth.ravi@sunnybrook.ca
Contact: Alexandru M Nicolae, MSc 416-910-7460 alexandru.nicolae@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N-3M5
Contact: Ananth Ravi, PhD    416-480-5000 ext 1092    ananth.ravi@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Ananth Ravi, PhD Sunnybrook Research Institute

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Responsible Party: Ananth Ravi, Medical Physicist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03660137     History of Changes
Other Study ID Numbers: Version 1.1.6
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ananth Ravi, Sunnybrook Health Sciences Centre:
Non-palpable lesion
Localization
Lumpectomy
Breast-Conserving Surgery
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases