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Computed Optical Margin Assessment for Breast Cancer Surgery

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Computed Optical Margin Assessment for Breast Cancer Surgery

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)

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Ex vivo ISAM sensitivity and specificity

Outcome Description:

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.

Outcome Time Frame:

one week after surgery

Safety Issue:


Principal Investigator

Lisa K Jacobs, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Institutional Review Board

Study ID:

DxP 2012-02



Start Date:

November 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • lumpectomy, breast caner, invasive ductal carcinoma, invasive lobular carcinoma, optical coherence tomography, ISAM, tumor margin, imaging
  • Breast Neoplasms



Anne Arundel Medical CenterAnnapolis, Maryland  21401
Johns Hopkins HospitalBaltimore, Maryland  21287