Breast Cancer
Conditions
Keywords
lumpectomy, breast cancer, optical coherence tomography, tumor margin, imaging
Brief summary
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.
Interventions
DEVICEOptical coherence tomography
Optical coherence tomography was used to image ex vivo breast tissue specimens.
Sponsors
Johns Hopkins University
Diagnostic Photonics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women 18 years of age or older 2. Signed informed consent form 3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery 4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Exclusion criteria
1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Neoadjuvant systemic therapy 3. All T4 tumors 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same quadrant 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 |
|---|---|---|
| Patients With All Positive Margins Correctly Identified With the Device | one week after surgery | In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink). |
| Number of Margins With False Positive Device Readings | one week after surgery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Optical Coherence Tomography (Single-arm) Specimens from all patients were evaluated by optical coherence tomography. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screening Failure | 3 |
Baseline characteristics
| Characteristic | Optical Coherence Tomography (Single-arm) |
|---|---|
| Age, Continuous | 62 years |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Number of Margins With False Positive Device Readings
Time frame: one week after surgery
Population: Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Optical Coherence Tomography (Single-arm) | Number of Margins With False Positive Device Readings | 1.32 False positive margins per patient | Standard Deviation 1.38 |
Primary
Patients With All Positive Margins Correctly Identified With the Device
In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink).
Time frame: one week after surgery
Population: Patients with positive margins (0 mm, tumor on ink).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Optical Coherence Tomography (Single-arm) | Patients With All Positive Margins Correctly Identified With the Device | 5 Patients w/ all positives identified |