Breast Cancer Female
Conditions
Keywords
Breast Biopsy, Breast Biopsy Imaging, Stereotactic Biopsy
Brief summary
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System as compared to the current standard-of-care breast biopsy procedures
Interventions
DEVICEBreast Biopsy
A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
Sponsors
Hologic, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female aged 18 years of age or older * Subject has at least one breast imaging finding requiring biopsy for which images are available * Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her
Exclusion criteria
* Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy. * Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Procedural Time in Minutes | Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes. | The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-biopsy Complication Rates | The time of consent until the subject procedure was completed, an average of 1 day | Adverse event percentage rates. |
| Number of Samples Collected Per Lesion | Samples collected from day of Breast Biopsy Procedure Only | Number of samples collected per lesion |
| Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only | The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brevera Breast Biopsy System The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging.
Breast Biopsy: A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous. | 316 |
| Standard of Care Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).
Breast Biopsy: A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous. | 209 |
| Total | 525 |
Baseline characteristics
| Characteristic | Brevera Breast Biopsy System | Standard of Care | Total |
|---|---|---|---|
| Age, Customized | 57.80 years STANDARD_DEVIATION 11.25 | 58.08 years STANDARD_DEVIATION 11.93 | 57.91 years STANDARD_DEVIATION 11.51 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 316 Participants | 209 Participants | 525 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 316 | 0 / 209 |
| other Total, other adverse events | 9 / 316 | 4 / 209 |
| serious Total, serious adverse events | 0 / 316 | 0 / 209 |
Outcome results
Primary
Difference in Procedural Time in Minutes
The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.
Time frame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.
Population: This study involved the participation of 525 female patients aged 18 years or older with suspicious findings on mammographic screening or diagnostic exams who were sent for breast biopsy. These subjects were enrolled at seven different clinical sites (75 subjects per site) and then separated to have their biopsy procedure performed using the current standard of care breast biopsy procedure (209) or the Brevera Breast Biopsy system (316).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brevera Breast Biopsy System | Difference in Procedural Time in Minutes | 42.15 procedure time in minutes | Standard Deviation 14.06 |
| Standard of Care | Difference in Procedural Time in Minutes | 40.13 procedure time in minutes | Standard Deviation 12.14 |
Secondary
Number of Samples Collected Per Lesion
Number of samples collected per lesion
Time frame: Samples collected from day of Breast Biopsy Procedure Only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brevera Breast Biopsy System | Number of Samples Collected Per Lesion | 6.69 samples obtained | Standard Deviation 3.39 |
| Standard of Care | Number of Samples Collected Per Lesion | 7.25 samples obtained | Standard Deviation 2.69 |
Secondary
Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients
The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion).
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brevera Breast Biopsy System | Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | 79.8 percentage of procedures |
| Standard of Care | Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | 72.8 percentage of procedures |
| Subject Feedback | Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | 99.0 percentage of procedures |
Secondary
Post-biopsy Complication Rates
Adverse event percentage rates.
Time frame: The time of consent until the subject procedure was completed, an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brevera Breast Biopsy System | Post-biopsy Complication Rates | 9 Participants |
| Standard of Care | Post-biopsy Complication Rates | 4 Participants |