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Computed Optical Margin Assessment for Breast Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Diagnostic Photonics, Inc.
Johns Hopkins University
Information provided by (Responsible Party):
Diagnostic Photonics, Inc. Identifier:
First received: October 2, 2012
Last updated: April 23, 2014
Last verified: April 2014

October 2, 2012
April 23, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
Ex vivo ISAM sensitivity and specificity [ Time Frame: one week after surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01699867 on Archive Site
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Computed Optical Margin Assessment for Breast Cancer Surgery
Computed Optical Margin Assessment for Breast Cancer Surgery

This study is a multi-center, prospective, open label study of approximately fifty (50) subjects at two (2) study sites, Johns Hopkins Hospital and Anne Arundel Medical Center. Patients scheduled to undergo lumpectomy will be recruited by the clinical investigators at the investigational site 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 samples using the study device during their lumpectomy.

This trial compares intraoperative imaging analysis of breast tumor margins to results from post-operative histology. The study will evaluate the ability to identify margin status (sensitivity and specificity) of intraoperative imaging vs. final pathology.

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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Women with breast cancer

Breast Cancer
Device: Interferometric Synthetic Aperture Microscopy
Optical Coherence Tomography (Interferometric Synthetic Aperture Microscopy) will be used to image ex vivo breast tissue specimens.
Other Name: Optical Coherence Tomography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2014   (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 invasive ductal carcinoma or invasive lobular 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
18 Years and older
Contact: Karyn Rhyder, RN 410-502-9693
United States
DxP 2012-02
Diagnostic Photonics, Inc.
Diagnostic Photonics, Inc.
Johns Hopkins University
Principal Investigator: Lisa K Jacobs, M.D. Johns Hopkins University
Diagnostic Photonics, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP