Palpable Breast CancerBCLNCT03573661
A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
A study testing Breast Cancer Locator (BCL) in people with Palpable Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
Trial summary
The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Palpable Breast Cancer
- What is being tested?
- Breast Cancer Locator (BCL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 May 2018to 5 Apr 2021
- 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
- Age > 18 years.
- Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ.
- Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
- The cancer enhances on prone breast MRI imaging
- The cancer is visible on mammography.
Who cannot join
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- Severe claustrophobia.
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (creatinine > 2.0).
- History of median sternotomy.
- Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- Patients receiving neoadjuvant chemotherapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lahey Hospital & Medical Center (Lahey Clinic)
Burlington, Massachusetts, 01805
Cheshire Medical Center
Keene, New Hampshire, 03431
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
St. Joseph Hospital
Nashua, New Hampshire, 03060
About this study
The project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.
Read the detailed description
The primary purpose of the study is to determine whether a device called the Breast Cancer Locator (BCL) accurately identifies the location of cancer in the breast. The Breast Cancer Locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. The location information is derived from an MRI which is obtained with the patient lying flat on their back (just as they are on an operating room table). The BCL is then custom-made for the patient using 3D printing technology.
The surgeon can feel the cancer, and the surgeon will remove the cancer by feeling the edges of it as the surgeon would normally. Since the cancer can be felt, the surgeon does not need an image guidance system such as the BCL to locate the cancer in the breast. Other women may have breast cancers that cannot be felt, but are only identified by mammography or MRI. If the BCL proves to accurately localize breast cancer, it may be a useful guide for the surgeon for these other women.
Additionally, the investigators want to determine whether this technology can be successfully employed at multiple sites and what, if any, complications occur during surgery as a result of using this device. The BCL has been used in 19 patients at Dartmouth with no complications.
- Conditions
- Palpable Breast Cancer
- Being tested
- Breast Cancer Locator (BCL)
- Keywords
- Breast Conserving Surgery, Breast Imaging, Breast Cancer Locator, Supine MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Locator (BCL)Device
This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Locator (BCL) | Experimental | The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. Receives: Device: Breast Cancer Locator (BCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram
Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).
Measured: Within approximately 60 Days post-surgery (all measures are collected by the time of patient follow-up visit within approximately 60 days after surgery, and recorded by the surgeon and radiologist in Case Report Forms (CRF forms).
Secondary outcomes (8)
Whether the study Radiologist can accurately define boundaries of the tumor from the supine MRI images
Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (tumor segregated accurately from supine MRI). The data is recorded by the radiologist on the CRF form.
Measured: Within approximately 60 days following surgery
Time from supine MRI to delivery of the Breast Cancer Locator (BCL) device to the surgeon
Unit of measure is in days. Final measure will be average days to delivery among all patients. The data is recorded by the surgeon on the CRF form.
Measured: Within approximately 60 days following surgery
Whether the BCL allowed the surgeon to successfully mark in/on the breast skin surface the items he or she needs to see during the surgery, including tumor edges and locations where wires will be placed
Yes/No answer from Surgeon. Final measure will be % of cases rated Yes (BCL enabled surgeon to successfully place all cues). The data is recorded by the surgeon on the CRF form.
Measured: Within approximately 60 days following surgery
Lumpectomy specimen volumes
Unit of measure is in mL, calculated by water displacement. Final measure will be average volume (mL) among all patients. The data is recorded by the study sponsor, Cairn Surgical, on the CRF form.
Measured: Within approximately 60 days following surgery
Operative times (Average time per operation)
Unit of measure is in minutes. Final measure will be average operative time (min.) among all patients. Data is collected by the surgeon from operative notes and placed in the CRF form.
Measured: Within approximately 60 days following surgery
The tumor margins, which the pathologist measures (as the distance from the tumor to the specimen edge)
Unit of measure is in cm. Final measure will be average margin (in cm) among all patients. Data is collected by the surgeon from the pathology report and reported in the CRF form.
Measured: Within approximately 60 days following surgery
Complications from surgery
Surgeon to list any complications - which could include infections or bruising. Final measure will be % of patients with complications. Data is collected from the surgeon either post-operatively, if there were operative complications; or at the post-operative follow-up appointment with the patient, if she reports any complications then. It is also possible this data could be collected at any time between surgery and follow up appointment by the patient calling the surgeon's office to report it. The surgeon records this data in the CRF form.
Measured: Within approximately 60 days following surgery
Surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator
Yes/No answer. Final measure will be % of surgeons who say Yes to satisfaction with the procedure. Data is collected from the surgeon and reported in the CRF form.
Measured: Within approximately 60 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start24 May 2018
- Primary completion24 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palpable Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
- Investigators
- Richard J Barth, Jr., MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573661
- Sponsor's protocol ID
- D16196
- Acronym
- BCL
- Status last verified
- May 2021
- First submitted
- 19 Jun 2018
- Last updated
- 25 May 2021
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Multi-Institutional Study to Evaluate the Accuracy of a Breast Cancer Locator in Patients With Palpable Cancers
- ClinicalTrials.gov ID
- NCT03573661
- Acronym / sponsor ID
- BCL / D16196
- Conditions
- Palpable Breast Cancer
- Keywords
- Breast Conserving Surgery, Breast Imaging, Breast Cancer Locator, Supine MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 29 Jun 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 project objective is to determine whether the Breast Cancer Locator (BCL) can safely and effectively localize breast cancers in patients treated at locations distant from the site of BCL manufacture. This information will be transmitted to CairnSurgical, Inc. where the BCL will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. The surgeon will then utilize the BCL at the time of resection of the palpable breast cancer.
Detailed description
The primary purpose of the study is to determine whether a device called the Breast Cancer Locator (BCL) accurately identifies the location of cancer in the breast. The Breast Cancer Locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. The location information is derived from an MRI which is obtained with the patient lying flat on their back (just as they are on an operating room table). The BCL is then custom-made for the patient using 3D printing technology.
The surgeon can feel the cancer, and the surgeon will remove the cancer by feeling the edges of it as the surgeon would normally. Since the cancer can be felt, the surgeon does not need an image guidance system such as the BCL to locate the cancer in the breast. Other women may have breast cancers that cannot be felt, but are only identified by mammography or MRI. If the BCL proves to accurately localize breast cancer, it may be a useful guide for the surgeon for these other women.
Additionally, the investigators want to determine whether this technology can be successfully employed at multiple sites and what, if any, complications occur during surgery as a result of using this device. The BCL has been used in 19 patients at Dartmouth with no complications.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Locator (BCL) | Experimental | Device: Breast Cancer Locator (BCL)The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years.
- Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ.
- Patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy).
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
- The cancer enhances on prone breast MRI imaging
Key exclusion criteria (6 listed)
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- Severe claustrophobia.
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (creatinine > 2.0).
- History of median sternotomy.
- Pregnancy. Patient attestation that they are not pregnant will be acceptable.
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)This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin. | Device | Breast Cancer Locator (BCL) |
Primary outcome
The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram
Time frame: Within approximately 60 Days post-surgery (all measures are collected by the time of patient follow-up visit within approximately 60 days after surgery, and recorded by the surgeon and radiologist in Case Report Forms (CRF forms).
Yes/No answer from Radiologist. Final measure will be % of cases rated Yes (wire deployed within the cancer on specimen mammogram).
8 secondary outcomes
Whether the study Radiologist can accurately define boundaries of the tumor from the supine MRI images
Time frame: Within approximately 60 days following surgery
Time from supine MRI to delivery of the Breast Cancer Locator (BCL) device to the surgeon
Time frame: Within approximately 60 days following surgery
Whether the BCL allowed the surgeon to successfully mark in/on the breast skin surface the items he or she needs to see during the surgery, including tumor edges and locations where wires will be placed
Time frame: Within approximately 60 days following surgery
Lumpectomy specimen volumes
Time frame: Within approximately 60 days following surgery
Operative times (Average time per operation)
Time frame: Within approximately 60 days following surgery
The tumor margins, which the pathologist measures (as the distance from the tumor to the specimen edge)
Time frame: Within approximately 60 days following surgery
Complications from surgery
Time frame: Within approximately 60 days following surgery
Surgeon satisfaction with the technical aspects of surgery guided by the Breast Cancer Locator
Time frame: Within approximately 60 days following surgery
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 25 May 2021.
Related trials for Palpable Breast Cancer
Not yet recruiting
IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors
Breast Cancer, Breast-Conserving Surgery
RecruitingObservational study
MEthods for LOcalization of Different Types of Breast Lesions
Breast Cancer
Active, not recruitingObservational study
Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study
Breast Cancer
Active, not recruitingObservational study
Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation
Breast Cancer
Active, not recruitingObservational study
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Breast Cancer
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.
Richard J Barth, Jr., MD principal investigator
Dartmouth-Hitchcock Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Locator (BCL) in people with Palpable Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
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 6 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The proportion of patients who had the localization wire placed within the cancer on the specimen mammogram (time frame: Within approximately 60 Days post-surgery (all measures are collected by the time of patient follow-up visit within approximately 60 days after surgery, and recorded by the surgeon and radiologist in Case Report Forms (CRF forms).). 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 25 May 2021.