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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02313116
Recruitment Status : Suspended
First Posted : December 9, 2014
Last Update Posted : July 18, 2019
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.

Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Device: Interferometric Synthetic Aperture Microscopy

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
Study Start Date : April 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. Patients With All Positive/Close Margins Correctly Identified With the Device [ Time Frame: 1 week after surgery ]
  2. Number of Margins With False Positive Device Readings [ Time Frame: 1 week after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02313116

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

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Responsible Party: Diagnostic Photonics, Inc. Identifier: NCT02313116     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part B)
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Keywords provided by Diagnostic Photonics, Inc.:
Breast cancer
Optical coherence tomography
Tumor margin
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases