Breast NeoplasmMOLLINCT04893421
Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
A study testing MOLLI Localization in people with Breast Neoplasm, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- MOLLI Localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Registry Study Evaluating the Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
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.
Read the 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, 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.
- Conditions
- Breast Neoplasm
- Being tested
- MOLLI Localization
- Keywords
- Non-palpable lesion, Localization, Lumpectomy, Breast-Conserving Surgery, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOLLI LocalizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care WGS or RSL | No intervention | 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. |
| MOLLI Localization | Experimental | 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. Receives: Device: MOLLI Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 (during surgical excision)
Secondary outcomes (8)
Specimen Margin Positivity
As reported by anatomical pathology, this metric will evaluate if the excised specimen has negative margins or positive margins.
Measured: Day 30
Re-excision rates
Follow-up will determine if patients required a re-excision / re-operation after determination of positive margin status.
Measured: Day 30
Duration of Excision
The time required to perform surgical excision of the lesion and MOLLI marker.
Measured: Day 3 (during surgery)
Duration of Implantation
The duration of MOLLI marker implantation as carried out by the radiologist.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start16 May 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, North York General Hospital
- Responsible party
- Principal investigator, Nicole Look Hong, Sunnybrook Health Sciences Centre
- Investigators
- Nicole Look Hong, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893421
- Sponsor's protocol ID
- 159-2019
- Acronym
- MOLLI
- Status last verified
- Nov 2024
- First submitted
- 14 May 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Look Hong N, Wright FC, Semple M, Nicolae AM, Ravi A. Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions. Breast Cancer Res Treat. 2020 Feb;179(3):671-676. doi: 10.1007/s10549-019-05499-z. Epub 2019 Nov 21.
PubMed 31754951
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study Evaluating the Magnetic Occult Lesion Localization Instrument (MOLLI) Guidance System for Breast Lesion Localization
- ClinicalTrials.gov ID
- NCT04893421
- Acronym / sponsor ID
- MOLLI / 159-2019
- Conditions
- Breast Neoplasm
- Keywords
- Non-palpable lesion, Localization, Lumpectomy, Breast-Conserving Surgery, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, North York General Hospital
- Study start
- 16 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care WGS or RSL | No intervention | –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. |
| MOLLI Localization | Experimental | Device: MOLLI LocalizationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Biologically male patients
- Locally advanced malignant breast cancer
- Any absolute contraindications to BCS
- Pregnancy or lactation
- Existing allergy to metallic seed materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOLLI LocalizationPatients 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 |
Primary outcome
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.
8 secondary outcomes
Specimen Margin Positivity
Time frame: Day 30
Re-excision rates
Time frame: Day 30
Duration of Excision
Time frame: Day 3 (during surgery)
Duration of Implantation
Time frame: Day 1 (localization)
Cost-effectiveness of MOLLI
Time frame: Day 1 (localization) and Day 3 (post surgery)
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)
State-Trait Anxiety Inventory (STAI) to evaluate anxiety
Time frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up)
Anxiety with Radiation
Time frame: Day 0 (baseline), Day 1 (localization) and Day 30 (1 month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 31754951Look Hong N, Wright FC, Semple M, Nicolae AM, Ravi A. Results of a phase I, non-randomized study evaluating a Magnetic Occult Lesion Localization Instrument (MOLLI) for excision of non-palpable breast lesions. Breast Cancer Res Treat. 2020 Feb;179(3):671-676. doi: 10.1007/s10549-019-05499-z. Epub 2019 Nov 21.
- Individual participant dataSharing planned: No
Related trials for Breast Neoplasm
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Look Hong, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOLLI Localization in people with Breast Neoplasm, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOLLI Localization Success Rate (time frame: Day 3 (during surgical excision)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.