Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

Diagnostic Photonics

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Optical coherence tomography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01699867

DxP 2012-02 (Part A)

Details and patient eligibility

About

This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women 18 years of age or older
2. Signed informed consent form
3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

Exclusion criteria

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study