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

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: NCT01699867
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : December 12, 2014
Last Update Posted : January 6, 2015
Johns Hopkins University
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.

October 2, 2012
October 4, 2012
December 5, 2014
December 12, 2014
January 6, 2015
December 2012
May 2013   (Final data collection date for primary outcome measure)
  • Patients With All Positive Margins Correctly Identified With the Device [ Time Frame: one week after surgery ]
    In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").
  • Number of Margins With False Positive Device Readings [ Time Frame: one week after surgery ]
Ex vivo ISAM sensitivity and specificity [ Time Frame: one week after surgery ]
The sensitivity and specificity of intraoperative imaging analysis to identify tumor on surgical specimen margins ex vivo when compared to blinded post-surgical histology findings.
Complete list of historical versions of study NCT01699867 on Archive Site
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Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Women with breast cancer undergoing lumpectomy
Breast Cancer
Device: Optical coherence tomography
Optical coherence tomography was used to image ex vivo breast tissue specimens.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2014
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
DxP 2012-02 (Part A)
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Diagnostic Photonics, Inc.
Diagnostic Photonics, Inc.
Johns Hopkins University
Principal Investigator: Lisa K Jacobs, M.D. Johns Hopkins University
Diagnostic Photonics, Inc.
December 2014