N/A N=50

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01699867 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Patients With All Positive Margins Correctly Identified With the Device — 5 Patients w/ all positives identified

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Optical coherence tomography (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Diagnostic Photonics, Inc.
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With All Positive Margins Correctly Identified With the Device	5	—
PRIMARY Number of Margins With False Positive Device Readings	1.32	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01699867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.