Clinical trial NCT05456373: Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Official title: Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
lumpectomy
positive surgical margins
Lead sponsor: LS BioPath
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, pivotal prospective, randomized clinical trial of the effect of imaging the excision specimen during surgical treatment of breast cancer
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of subjects with positive margins post-op
timeFrame: In the operating room compared to pathology assessment within 1 week post-op
Secondary outcomes:
measure: FN and FP rates
timeFrame: within weeks post-op
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
Study officials:
affiliation: University of California, San Francisco Medical Center
name: Jasmine Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: