Breast Cancer FemaleNCT04397185
Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
A study testing Breast Cancer Locator (BCL) guided partial mastectomy and Wire Localized (WL) partial mastectomy in people with Breast Cancer Female, run by CairnSurgical, Inc. at 23 sites in 4 countries.
Trial summary
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Breast Cancer Locator (BCL) guided partial mastectomy and Wire Localized (WL) partial mastectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 23 Dec 2020to 9 Dec 2025
- 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
- Female gender
- Age > 18 years
- Histologic diagnosis of invasive breast cancer or DCIS
- The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
- The tumor is unifocal or multifocal with satellite lesions < or = 2 cm from primary tumor
- The tumor enhances on prone breast MRI imaging
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- The tumor is ≥ 1 cm in diameter on prone breast MRI
- Subject and surgeon agree to perform BCS
- Subject voluntarily provides informed consent
Who cannot join
- Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
- Severe claustrophobia that precludes prone or supine MRI
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
- Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
- Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed
- Subjects who have received or plan to receive neoadjuvant chemotherapy
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- Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position
- Measurement of widest circumference around breasts and arms > 135 cm for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms >145 cm for sites using 70 cm bore scanners
- Subjects with known allergy to materials present in the device
- Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe)
- Subject would require > 2 localization wires, if randomized to standard of care
- Subjects with multicentric tumors (additional tumors > 2 cm from primary)
- Subject would require chest wall muscle nerve block as part of the operation
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States19 sites
St. Peter's Hospital
Albany, New York, 12208
Tufts Medical Center
Boston, Massachusetts, 02111
Mass General/North Shore Center for Outpatient Care
Danvers, Massachusetts, 01923
Steward Medical Group
Easton, Massachusetts, 02356
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Summit Health
Florham Park, New Jersey, 07932
MD Anderson Cancer Center
Houston, Texas, 77030
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Cheshire Medical Center
Keene, New Hampshire, 03431
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Catholic Medical Center
Manchester, New Hampshire, 03102
Hennepin Healthcare
Minneapolis, Minnesota, 55415
St. Joseph Hospital
Nashua, New Hampshire, 03060
Columbia University Irving Medical Center and New York-Presbyterian Hospital
New York, New York, 10032
Women and Infants Hospital
Providence, Rhode Island, 02905
Rutland Regional Medical Center
Rutland, Vermont, 05701
Arizona Center for Cancer Care
Scottsdale, Arizona, 85258
Moffitt Cancer Center
Tampa, Florida, 33612
Kent Hospital
Warwick, Rhode Island, 02886
United Kingdom2 sites
Basildon University Hospital
Basildon
Manchester University NHS
Manchester
About this study
Official title: Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.
Read the detailed description
The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS.
Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.
- Conditions
- Breast Cancer Female
- Being tested
- Breast Cancer Locator (BCL) guided partial mastectomy, Wire Localized (WL) partial mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Locator (BCL) guided partial mastectomyDevice
The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
Wire Localized (WL) partial mastectomyDevice
Standard of care procedure
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Locator (BCL) | Experimental | Subject randomized to BCL surgical guidance to perform partial mastectomy Receives: Device: Breast Cancer Locator (BCL) guided partial mastectomy |
| Wire Localization (WL) | Active comparator | Subject randomized to WL surgical guidance to perform partial mastectomy Receives: Device: Wire Localized (WL) partial mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive margin rate
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Secondary outcomes (7)
Specimen volumes
To compare specimen volumes for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Re-excision rate
To compare re-excision rate for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Cancer localization rate
To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Operative times
To compare operative times for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Adverse event rate
To compare adverse event rate for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Rate of additional shave biopsies
To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Costs of care
To compare costs of care for women randomized to BCL vs. WL-guided BCS
Measured: At completion of study recruitment, approximately 18 months after first subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start23 Dec 2020
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- CairnSurgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Gass, MD, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397185
- Sponsor's protocol ID
- BCL IDE
- Status last verified
- Jan 2026
- First submitted
- 15 May 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial of Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
- ClinicalTrials.gov ID
- NCT04397185
- Acronym / sponsor ID
- BCL IDE
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- CairnSurgical, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 21 May 2020 (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.
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.
Detailed description
The BCL System is intended to be used to guide a surgeon when performing partial mastectomy for breast cancer and to minimize positive margins. The purpose of this study is to provide evidence that the BCL is safe, effective, and non-inferior to the standard of care (WL) in the removal of non-palpable invasive breast cancer and DCIS.
Investigators in the intervention group will be provided with a three dimensional (3D) image of the cancer in the breast which allows them to visualize the closest distance from the tumor to the skin and the chest wall and quantifies those distances. Investigators will also use a BCL, which is a patient specific, plastic, bra-like form that is transiently placed on the breast prior to surgery and allows the Investigator to mark the projected edges of the tumor on the breast skin and to place bracketing wires inside the breast which define the center of the cancer and distances 1 cm from the tumor edges defined by pre-operative supine MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Locator (BCL) | Experimental | Device: Breast Cancer Locator (BCL) guided partial mastectomySubject randomized to BCL surgical guidance to perform partial mastectomy |
| Wire Localization (WL) | Active comparator | Device: Wire Localized (WL) partial mastectomySubject randomized to WL surgical guidance to perform partial mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female gender
- Age > 18 years
- Histologic diagnosis of invasive breast cancer or DCIS
- The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
- The tumor is unifocal or multifocal with satellite lesions < or = 2 cm from primary tumor
Key exclusion criteria (13 listed)
- Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
- Severe claustrophobia that precludes prone or supine MRI
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
- Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
- Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed
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 |
|---|---|---|
| Breast Cancer Locator (BCL) guided partial mastectomyThe BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery. | Device | Breast Cancer Locator (BCL) |
| Wire Localized (WL) partial mastectomyStandard of care procedure | Device | Wire Localization (WL) |
Primary outcome
Positive margin rate
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance
7 secondary outcomes
Specimen volumes
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
Re-excision rate
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
Cancer localization rate
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
Operative times
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
Adverse event rate
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
Rate of additional shave biopsies
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
Costs of care
Time frame: At completion of study recruitment, approximately 18 months after first subject enrolled
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 20 Jan 2026.
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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.
Jennifer Gass, MD principal investigator
Women & Infants Hospital
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Locator (BCL) guided partial mastectomy and Wire Localized (WL) partial mastectomy in people with Breast Cancer Female, run by CairnSurgical, Inc. at 23 sites in 4 countries.
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 9 inclusion and 13 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, United Kingdom, Austria, 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?
Positive margin rate (time frame: At completion of study recruitment, approximately 18 months after first subject enrolled). 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 20 Jan 2026.