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

NCT02313116 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-07-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Interferometric Synthetic Aperture Microscopy

Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.

Sponsors & Collaborators

  • Diagnostic Photonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Jacobs · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2020-02-29
Completion
2020-03-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313116 on ClinicalTrials.gov