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

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ClinicalTrials.gov Identifier: NCT04893421
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : September 27, 2021
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
North York General Hospital
Information provided by (Responsible Party):
Nicole Look Hong, Sunnybrook Health Sciences Centre

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 Instrument (MOLLI), an approved instrument 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. Patients will eventually be enrolled across 3 surgical sites (Sunnybrook Health Sciences Centre - primary site, Princess Margaret Cancer Centre, and North York General Hospital) over a 2 year period. Patient and system-related outcome measures will first be collected using the centre-specific standard of care (Wire-Guided Localization or Radioactive Seed Localization for BCS) to establish a baseline. Subsequently, centers will transition to the MOLLI system, recording corresponding outcomes to be used for temporal comparison. The overall objective of this study is to evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care approaches.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: At each site, the first cohort of 25 participants will be treated with the standard of care approach (WGS or RSL) and the subsequent cohort of 25 participants will be treated with MOLLI.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Registry Study Evaluating the Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
Actual Study Start Date : May 16, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care WGS or RSL
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.
Experimental: MOLLI Localization
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.
Device: MOLLI Localization
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.




Primary Outcome Measures :
  1. MOLLI Localization Success Rate [ Time Frame: Day 3 (during surgical excision) ]
    To determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance compared to standard of care approaches.


Secondary Outcome Measures :
  1. 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.

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

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

  4. Duration of Implantation [ Time Frame: Day 1 (localization) ]
    The duration of MOLLI marker implantation as carried out by the radiologist.

  5. Cost-effectiveness of MOLLI [ Time Frame: Day 1 (localization) and Day 3 (post surgery) ]
    Operating costs and efficiency data of SOC and MOLLI techniques (including disposables, start-up equipment, human resources, timing data for operating and radiology).

  6. Hospital Anxiety and Depression Scale (HADS) to evaluate anxiety and depression [ Time Frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up) ]
    HADS will evaluate anxiety and depression pre and post localization and surgery. Questions will be evaluated on a 4 point scale. Evaluations will occur prior to localization, following localization and approximately 1 month following surgical excision. Higher scores indicate greater anxiety and/or depression.

  7. State-Trait Anxiety Inventory (STAI) to evaluate anxiety [ Time Frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up) ]
    STAI will evaluate anxiety pre and post localization and surgery. Questions will be evaluated on a 4 point scale. Evaluations will occur prior to localization, following localization and approximately 1 month following surgical excision. Higher scores indicate greater anxiety.

  8. Anxiety with Radiation [ Time Frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up) ]
    Anxiety specific to the radioactive seed (for those receiving RSL as the standard of care approach) will be assessed using a questionnaire pre and post localization and surgery. Two questions will be evaluated on a 4 point scale. Evaluations will occur prior to localization, following localization and approximately 1 month following surgical excision. Higher scores indicate greater anxiety.



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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 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 Criteria:

  • 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

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): NCT04893421


Contacts
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Contact: Nicole Look Hong, MD 416-480-4210 nicole.lookhong@sunnybrook.ca
Contact: Ananth Ravi, PhD aravi@mollisurgical.com

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N-3M5
Contact: Sarah Selvadurai, MSc    416-480-6100 ext 89834    sarah.selvadurai@sunnybrook.ca   
Principal Investigator: Nicole Look Hong, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Princess Margaret Hospital, Canada
North York General Hospital
Investigators
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Principal Investigator: Nicole Look Hong, MD Sunnybrook Health Sciences Centre
Publications:
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Responsible Party: Nicole Look Hong, Surgical Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04893421    
Other Study ID Numbers: 159-2019
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Nicole Look Hong, 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