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Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

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ClinicalTrials.gov Identifier: NCT05456373
Recruitment Status : Not yet recruiting
First Posted : July 13, 2022
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
LS BioPath

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
Breast Cancer Device: ClearEdge device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Estimated Study Start Date : August 31, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Percentage of subjects with positive margins post-op [ Time Frame: 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 :
  1. FN and FP rates [ Time Frame: within weeks post-op ]
    The per-patient FN rate and FP rate for SoC compared to permanent section pathology



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05456373


Contacts
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Contact: Moshe Sarfaty, PhD 408-464-4051 moshe@lsbiopath.com
Contact: Catherine Kusnick, MD 9496369601 ckusnick@alum.wellesley.edu

Sponsors and Collaborators
LS BioPath
Investigators
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Principal Investigator: Jasmine Wong, MD University of California, San Francisco Medical Center
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Responsible Party: LS BioPath
ClinicalTrials.gov Identifier: NCT05456373    
Other Study ID Numbers: LSB-12345
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Possibly to Study Site PIs

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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
Keywords provided by LS BioPath:
breast cancer
lumpectomy
positive surgical margins
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases