Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment interferometric synthetic aperture microscopy
Sponsor Diagnostic Photonics, Inc.
Start date April 2014
End date December 2016
Trial size 50 participants
Trial identifier NCT02313116, DxP 2012-02 (Part B)

Summary

This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Patients With All Positive/Close Margins Correctly Identified With the Device
time frame: 1 week after surgery
Number of Margins With False Positive Device Readings
time frame: 1 week after surgery

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Principal investigator Lisa Jacobs
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Diagnostic Photonics, Inc..