Breast Cancer
Conditions
Keywords
breast cancer, lumpectomy, positive surgical margins
Brief summary
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
Detailed description
ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.
Interventions
DEVICEClearEdge device
ClearEdge tissue imaging device uses a new technology to detect tissue abnormalities at the surgical margins of a surgically excised breast tissue specimen. Adding the use of the imaging device has the potential to assist the surgeon in identifying DCIS or invasive cancer involved margins of the excised specimen.
Sponsors
LS BioPath
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multi-center, pivotal prospective, randomized clinical trial of the effect of imaging the excision specimen during surgical treatment of breast cancer
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are female (genotype) 2. Patients aged above 18 years, inclusive 3. Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure 4. Patients treated with neoadjuvant endocrine therapy may be enrolled
Exclusion criteria
1. Patients currently receiving chemotherapy 2. Patients having prior ipsilateral surgical treatment for breast cancer 3. Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma) 4. Patients who have breast implants 5. Patients who are pregnant and/or lactating 6. Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with positive margins post-op | In the operating room compared to pathology assessment within 1 week post-op | The percentage of patients with DCIS or invasive cancer involved margins as determined by pathology PM after evaluation with SoC or SoC+ClearEdge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FN and FP rates | within weeks post-op | The per-patient FN rate and FP rate for SoC compared to permanent section pathology |
Countries
United States
Contacts
Primary ContactMoshe Sarfaty, PhD
Backup ContactCatherine Kusnick, MD
Outcome results
None listed