Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Breast Cancer Clinical Trial

Official title:

Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456373
• Other study ID #: LSB-12345
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: LS BioPath
• Contact: Moshe Sarfaty, PhD
• Phone: 408-464-4051
• Email: moshe[@]lsbiopath.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	UCSF Medical Center at Mission Bay	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
LS BioPath

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	In the operating room compared to pathology assessment within 1 week post-op
Secondary	FN and FP rates	The per-patient FN rate and FP rate for SoC compared to permanent section pathology	within weeks post-op