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Trial record 2 of 7 for:    breast cancer optical margins assessment

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

This study has suspended participant recruitment.
Information provided by (Responsible Party):
Diagnostic Photonics, Inc. Identifier:
First received: December 5, 2014
Last updated: December 13, 2016
Last verified: December 2016
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.

Condition Intervention
Breast Cancer Device: Interferometric Synthetic Aperture Microscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

Resource links provided by NLM:

Further study details as provided by Diagnostic Photonics, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Interferometric Synthetic Aperture Microscopy
    Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.
    Other Name: Optical Coherence Tomography

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with breast cancer undergoing lumpectomy.

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
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Please refer to this study by its identifier: NCT02313116

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Diagnostic Photonics, Inc.
Principal Investigator: Lisa Jacobs Johns Hopkins University
  More Information

Responsible Party: Diagnostic Photonics, Inc. Identifier: NCT02313116     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part B)
Study First Received: December 5, 2014
Last Updated: December 13, 2016

Keywords provided by Diagnostic Photonics, Inc.:
Breast cancer
Optical coherence tomography
Tumor margin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on August 18, 2017