Breast Cancer
Conditions
Brief summary
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.
Detailed description
The aim of this interventional, post-market, multicenter clinical investigation is to evaluate the performance of a custom-made medical device, the Breast Cancer Locator (BCL) system, in subjects with non-palpable breast cancer. The study will be conducted in European countries. To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained. Each Subject, after signing an Informed Consent Form (ICF), will enter into a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) will be conducted. At visit 1, the Subject will undergo supine MRI, from which a 3D breast image and BCL will be made. At visit 2, the patient will undergo Breast Conserving Surgery (BCS) using the BCL system. On the same day, the specimen volume will be determined. The excised specimen will be sent to the pathological lab for analysis. The results, including the positive margin rate (PMR) and specimen mammogram, will be obtained within 14 days. At visit 3, follow-up assessments (including physical examination, and adverse event review) will be performed. At the End Of Study visit, adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q.
Interventions
DEVICEBreast Cancer Locator Guided Breast Conserving Surgery
Subjects will undergo a contrast-enhanced supine MRI and two marks will be placed on the breast. The MRI images will be transmitted to the sponsor, and the images will be used to build a BCL using 3D printing. Investigators will be provided with a 3D image of the cancer in the breast. Investigators will use a BCL (a patient-specific, plastic, bra-like form that is placed on the breast and allows the investigator to mark the edges of the tumor on the skin and to place wires inside the breast which define the center of the cancer and the tumor edges. The surgeon will then attempt to surgically remove all the tissue inside the wires used to define the tumor edges.
Sponsors
CairnSurgical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will undergo breast conserving surgery with the BCL.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient Informed consent form (ICF) signed * Female Aged ≥ 18 years at the time of the signature of ICF * Histologic diagnosis of IBC or DCIS * Tumor excision that will require localization because it cannot be definitively defined by palpation * The tumor is unifocal; possible satellite lesions \< 2 cm from primary are eligible * The tumor enhances and is greater than or equal to 5mm on prone breast MRI imaging * Subject and surgeon agree to perform BCS * Willingness to follow all study procedures, including attending all site visits, tests and examinations.
Exclusion criteria
* 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 * Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy * Uncontrolled cardiac, renal, or pulmonary disease * Uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma) * Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury * Pregnancy or breast-feeding * Subjects who have received or plan to receive neoadjuvant chemotherapy * 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 * Known allergy to device components * Multicentric tumors (additional tumors \> 2 cm from primary) * Infectious or inflammatory processes near the area of intervention * Planned surgery with localization devices including WGL, intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices * Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion * Known drug and/or alcohol abuse * Mental incapacity that precludes adequate understanding or cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Margin Rate | Pathology results from the index procedure available within 14 days from the day of sample arrival at the pathological lab. | To evaluate the performance of BCL in reducing the positive margin rate, the proportion of patients with positive margins after partial mastectomy with the BCL was obtained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specimen Volume | Results obtained the same day of surgery. | To calculate the specimen volume after BCL guided partial mastectomy, the water displacement method (WDM) was used. |
| Surgeon's Perception | Results will be obtained prior to subject discharge after the study procedure (within approximately 2 days after surgery) | To evaluate the surgeon's perception of the BCL system, a survey asking them if they strongly disagree, somewhat disagree, are undecided, somewhat agree, or strongly agree that the BCL made tumor localization easier, was easy to use, made tumor excision easier, and would be recommended by them, will be used. |
| Number of Participants With Adverse Events | From supine MRI 10-40 days prior to surgery through 6 weeks +/- 7 days post surgery | To evaluate the safety and tolerability of BCL, adverse events will be reported, including frequency, maximum intensity, relation to study treatment, seriousness, action taken, and outcome. Safety data will be handled descriptively. |
| Patient Satisfaction | 6 weeks +/- 7 days post surgery | To evaluate the patient's satisfaction, the BREAST-Q patient-reported outcome measure will be used. Patient satisfaction scores range from 0-100, with a higher score meaning greater satisfaction or better quality of life. |
Countries
Germany, Italy, Switzerland
Contacts
STUDY_DIRECTORRichard J Barth, MD
Cairn Surgical
Participant flow
Recruitment details
Adult women with a diagnosis by pre-operative biopsy of non-palpable breast cancer were recruited from patients at participating sites. Patients were recruited from June 2022 to May 2024.
Pre-assignment details
After signing the informed consent form, each subject entered a screening phase, during which several assessments (e.g., demographics, medical history, evaluation of available prone MRI and core biopsy pathological results) were conducted. Blood samples were also collect. A total of 45 patients were screened; however, 6 patients were excluded due to screening failure and 4 patients because surgery could not be performed with BCL. All remaining 35 patients were treated with BCL.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.54 years STANDARD_DEVIATION 11.17 |
| BREAST-Q Rasch score | 67 scores on a scale STANDARD_DEVIATION 18 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 31 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 10 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
None listed