Breast Cancer
Conditions
Keywords
IDC, DCIS, ILC
Brief summary
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
Detailed description
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a Standard of Care (SOC) Control group and the other arm a Device+SOC group.In the Device +SOC group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
Interventions
DEVICEMarginProbe
Device use to assess margin status of the excised specimen surface.
PROCEDURELumpectomy
Standard of care lumpectomy procedure
Sponsors
Dune Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Women histologically diagnosed with carcinoma of the breast 2. Women with non-palpable malignant lesions, requiring image guided localization. 3. Undergoing lumpectomy (partial mastectomy) procedure. 4. Age 18 years or more 5. Signed ICF
Exclusion criteria
1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Bilateral disease (diagnosed cancer in both breasts) 3. Neoadjuvant systemic therapy 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same breast 6. Implants in the operated breast 7. Pregnancy 8. Lactation 9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. | two weeks after surgery | Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SOC) Standard of Care arm - standard of care lumpectomy procedure
Lumpectomy: Standard of care lumpectomy procedure | 298 |
| Device + (Standard of Care) SOC Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure | 298 |
| Total | 596 |
Baseline characteristics
| Characteristic | Standard of Care (SOC) | Device + (Standard of Care) SOC | Total |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 11.1 | 60.3 years STANDARD_DEVIATION 11.4 | 60.3 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 298 Participants | 298 Participants | 596 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 298 | 0 / 298 | 0 / 68 |
| serious Total, serious adverse events | 5 / 298 | 6 / 298 | 3 / 68 |
Outcome results
Primary
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively
Time frame: two weeks after surgery
Population: The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen (PSS - Positive specimen subjects)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SOC) | The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. | 22.4 percentage of participants analyzed |
| Device + (Standard of Care) SOC | The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. | 71.8 percentage of participants analyzed |
p-value: <0.0001Fisher Exact
Post Hoc
Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens
Time frame: Up to 2 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SOC) | Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens | 20.8 percentage of participants |
| Device + (Standard of Care) SOC | Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens | 10.0 percentage of participants |
p-value: 0.002Fisher Exact