Breast NeoplasmsMOLLINCT03660137
Magnetic Occult Lesion Localization and Imaging (MOLLI)
A study testing MOLLI Localization in people with Breast Neoplasms, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- 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
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 May 2018to 1 Jan 2020
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial
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.
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.
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 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.
WHAT WILL HAPPEN DURING THE STUDY?
As part of this study, researchers will look at how safe the MOLLI system is in finding the tumor in the participant's breast. The study will also gather information on the participant's experience of having the MOLLI seed placed. Participants will undergo both MOLLI as well as the current standard method, RSL, ensuring that the area of concern will be accurately located and then removed. Approximately 20 women will take part in this study
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 following both visits
- 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 your procedure to take part in a short telephone questionnaire. The questionnaire should take no more than 5 minutes to complete.
- Conditions
- Breast Neoplasms
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| MOLLI Localization | Experimental | 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. 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
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.
Measured: Day 3 post marker implantation (during surgical excision)
Secondary outcomes (6)
Duration of Implantation
The duration of MOLLI marker implantation as carried out by the radiologist.
Measured: Day 0 (during marker implantation)
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 at 30 days
Follow-up will determine if patients required a re-excision / re-operation after determination of positive margin status.
Measured: Day 30
European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life
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.
Measured: Day 0 (baseline), Day 30 (1 month FU)
Duration of Excision
The time required to perform surgical excision of the lesion and MOLLI marker.
Measured: Day 3 (during surgery)
European Quality-of-Life Visual Analogue Scale (EQVAS) questionnaire to evaluate quality-of-life
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.
Measured: Day 0 (baseline), Day 30 (1 month FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start28 May 2018
- Primary completion1 Jun 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive both RSL and MOLLI-guided lumpectomy surgery
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ananth Ravi, Sunnybrook Health Sciences Centre
- Investigators
- Ananth Ravi, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660137
- Sponsor's protocol ID
- Version 1.1.6
- Acronym
- MOLLI
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Occult Lesion Localization and Imaging (MOLLI) for Non-palpable Breast Lesions: a Phase 0 Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT03660137
- Acronym / sponsor ID
- MOLLI / Version 1.1.6
- Conditions
- Breast Neoplasms
- Keywords
- Non-palpable lesion, Localization, Lumpectomy, Breast-Conserving Surgery, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 6 Sep 2018 (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, 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.
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.
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 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.
WHAT WILL HAPPEN DURING THE STUDY?
As part of this study, researchers will look at how safe the MOLLI system is in finding the tumor in the participant's breast. The study will also gather information on the participant's experience of having the MOLLI seed placed. Participants will undergo both MOLLI as well as the current standard method, RSL, ensuring that the area of concern will be accurately located and then removed. Approximately 20 women will take part in this study
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 following both visits
- 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 your 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive both RSL and MOLLI-guided lumpectomy surgery
| Arm | Type | Receives |
|---|---|---|
| MOLLI Localization | Experimental | Device: MOLLI LocalizationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 LocalizationAll 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. | Device | MOLLI Localization |
Primary outcome
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.
6 secondary outcomes
Duration of Implantation
Time frame: Day 0 (during marker implantation)
Specimen Margin Positivity
Time frame: Day 30
Re-excision rates at 30 days
Time frame: Day 30
European Quality-of-Life Questionnaire - 5 Dimensions (EQ5D) questionnaire to evaluate quality-of-life
Time frame: Day 0 (baseline), Day 30 (1 month FU)
Duration of Excision
Time frame: Day 3 (during surgery)
European Quality-of-Life Visual Analogue Scale (EQVAS) questionnaire to evaluate quality-of-life
Time frame: Day 0 (baseline), Day 30 (1 month FU)
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 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ananth Ravi, PhD principal investigator
Sunnybrook Research Institute
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 Neoplasms, 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 4 inclusion and 7 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 17 Mar 2020. 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 post marker implantation (during surgical excision)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2020.