Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

LS BioPath

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: ClearEdge device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05456373

LSB-12345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

SoC+ClearEdge device - Standard of Care + study device

Experimental group

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

Treatment:

Device: ClearEdge device

SoC - Standard of Care

No Intervention group

Description:

Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery