An interventional study of MOLLI Localization in Breast Neoplasm, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
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, patient experience, and treatment workflow efficiency during the therapeutic process have considerable room for improvement.
BCS consists of a surgical procedure whereby the suspicious tumor and a rim of surrounding normal tissue are removed. Up to one-third of all diagnosed breast cancers are non-palpable,and require some form of pre-operative localization to guide precise surgical excision. Currently, options for localization of non-palpable lesions are suboptimal in terms of patient experience, healthcare system resource utilization, and cost-effectiveness.
One of the most common approaches is radioactive seed localization (RSL). RSL consists of insertion of a small radioactive seed under ultrasound guidance to mark the center and/or borders of the tumor. During the procedure the surgeon uses a hand-held probe to detect the seed and guide surgical excision of the lesion intra-operatively. While RSL is effective the use of a radioactive source is and poses many challenges for patients and staff. Another common approach is wired-guided localization (WGL). WGL involves implantation of a hooked wire to mark the center or outer edges of the lesion. Due to modest cost and relative ease of use, WGL use is widespread, however disadvantages include significant patient discomfort, possible migration of the implanted wire, and potential difficulties in localizing axillary lymph nodes.
WHAT ARE THE INVESTIGATORS DOING?
The investigative team of surgeons and scientists are examining an alternative approach to BCS called magnetic occult lesion localization and imaging (MOLLI). Analogous to RSL, this procedure involves implantation of a small passive magnetic seed - under ultrasound or mammographic imaging guidance - directly into or surrounding the tumor; during the procedure the surgeon uses a novel hand-held probe to intra-operatively detect the position of this seed and remove the tumor.
WHY IS THE STUDY BEING CONDUCTED?
MOLLI offers many of the same benefits as RSL but without any radiation. MOLLI also has the potential to be more effective and accurate than other localization methods. MOLLI has recently been evaluated as part of a phase I clinical trial and was demonstrated to be a safe and effective localization technology. The goal for the current trial is to evaluate clinical and health economic outcomes with MOLLI compared to standard-of-care approaches to help improve access to a wireless, low-cost, but effective breast lesion localization technology for breast cancer patients.
WHAT WILL HAPPEN DURING THE STUDY?
As part of this study, researchers will 1) evaluate identify barriers and facilitators related to MOLLI based on feedback from clinical staff, 2) demonstrate cost-effectiveness of MOLLI and 3) gather information on the participants' experience with the MOLLI seed. At each site, the first 25 participants will be treated with the standard of care for BCS (RSL or WGL), and the second 25 participants will be treated with MOLLI.
ARE THERE SIDE EFFECTS?
No side effects are expected from the study treatments. Possible risks associated with using MOLLI include:
A small risk of bleeding A remote risk of allergic reaction to nickel contained in the MOLLI seeds
WHAT WILL HAPPEN AFTER THE STUDY?
Participants may be contacted by a study team member up to and including 16 weeks (6.5 months) after the procedure to take part in a short telephone questionnaire. The questionnaire should take no more than 5 minutes to complete.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 41 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
MOLLI Localization Success Rate
To determine the success rate of localizing the MOLLI seed, along with subsequent accurate removal under MOLLI guidance compared to standard of care approaches.
Time frame: Day 3 (during surgical excision)
Specimen Margin Positivity
As reported by anatomical pathology, this metric will evaluate if the excised specimen has negative margins or positive margins.
Time frame: Day 30
Re-excision rates
Follow-up will determine if patients required a re-excision / re-operation after determination of positive margin status.
Time frame: Day 30
Duration of Excision
The time required to perform surgical excision of the lesion and MOLLI marker.
Time frame: Day 3 (during surgery)
Duration of Implantation
The duration of MOLLI marker implantation as carried out by the radiologist.
Time frame: Day 1 (localization)
Cost-effectiveness of MOLLI
Operating costs and efficiency data of SOC and MOLLI techniques (including disposables, start-up equipment, human resources, timing data for operating and radiology).
Time frame: Day 1 (localization) and Day 3 (post surgery)
Hospital Anxiety and Depression Scale (HADS) to evaluate anxiety and depression
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.
Time frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up)
State-Trait Anxiety Inventory (STAI) to evaluate anxiety
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.
Time frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up)
Anxiety with Radiation
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.
Time frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up)
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sunnybrook Health Sciences Centre