Back to resultsIntraoperative Use of ClearEdge Device in Breast Conserving Surgery
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClearEdge device
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, lumpectomy, positive surgical margins
Eligibility Criteria
Inclusion Criteria:
- Patients who are female (genotype)
- Patients aged above 18 years, inclusive
- Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
- Patients treated with neoadjuvant endocrine therapy may be enrolled
Exclusion Criteria:
- Patients currently receiving chemotherapy
- Patients having prior ipsilateral surgical treatment for breast cancer
- 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)
- Patients who have breast implants
- Patients who are pregnant and/or lactating
- Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
Sites / Locations
- UCSF Medical Center at Mission BayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SoC+ClearEdge device - Standard of Care + study device
SoC - Standard of Care
Arm Description
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
Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery
Outcomes
Primary Outcome Measures
Percentage of subjects with positive margins 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
The per-patient FN rate and FP rate for SoC compared to permanent section pathology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05456373
Brief Title
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Official Title
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LS BioPath
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, lumpectomy, positive surgical margins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multi-center, pivotal prospective, randomized clinical trial of the effect of imaging the excision specimen during surgical treatment of breast cancer
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SoC+ClearEdge device - Standard of Care + study device
Arm Type
Experimental
Arm Description
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
Arm Title
SoC - Standard of Care
Arm Type
No Intervention
Arm Description
Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery
Intervention Type
Device
Intervention Name(s)
ClearEdge device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of subjects with positive margins post-op
Description
The percentage of patients with DCIS or invasive cancer involved margins as determined by pathology PM after evaluation with SoC or SoC+ClearEdge.
Time Frame
In the operating room compared to pathology assessment within 1 week post-op
Secondary Outcome Measure Information:
Title
FN and FP rates
Description
The per-patient FN rate and FP rate for SoC compared to permanent section pathology
Time Frame
within weeks post-op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are female (genotype)
Patients aged above 18 years, inclusive
Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
Patients treated with neoadjuvant endocrine therapy may be enrolled
Exclusion Criteria:
Patients currently receiving chemotherapy
Patients having prior ipsilateral surgical treatment for breast cancer
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)
Patients who have breast implants
Patients who are pregnant and/or lactating
Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moshe Sarfaty, PhD
Phone
408-464-4051
Email
moshe@lsbiopath.com
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Kusnick, MD
Phone
9496369601
Email
ckusnick@alum.wellesley.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmine Wong, MD
Organizational Affiliation
University of California, San Francisco Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Wong, MD
Phone
415-353-7070
Email
Jasmine.Wong2@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Possibly to Study Site PIs
Learn more about this trial
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
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