Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SoC+ClearEdge device - Standard of Care + study device Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery plus the use of the study device to assess for breast cancer cells at the the margins |
Device: ClearEdge 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.
|
| No Intervention: SoC - Standard of Care Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- FN and FP rates [within weeks post-op]
The per-patient FN rate and FP rate for SoC compared to permanent section pathology
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who are female (genotype)
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Patients aged above 18 years, inclusive
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Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
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Patients treated with neoadjuvant endocrine therapy may be enrolled
Exclusion Criteria:
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Patients currently receiving chemotherapy
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Patients having prior ipsilateral surgical treatment for breast cancer
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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)
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Patients who have breast implants
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Patients who are pregnant and/or lactating
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Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- LS BioPath
Investigators
- Principal Investigator: Jasmine Wong, MD, University of California, San Francisco Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LSB-12345