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Computed Optical Margin Assessment for Breast Cancer Surgery

This study is currently recruiting participants.
Verified November 2012 by Diagnostic Photonics, Inc.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier:
NCT01699867
First received: October 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with breast cancer

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699867

Contacts
Contact: Karyn Rhyder, RN 410-502-9693 kriedal1@jhmi.edu

Locations
United States, Maryland
Anne Arundel Medical Center Not yet recruiting
Annapolis, Maryland, United States, 21401
Contact: Kristen Sawyer, M.S.     443-481-5749     ksawyer@aahs.org    
Sub-Investigator: Lorraine Tafra, M.D.            
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21231
Contact: Karyn Rhyder, R.N.     410-502-9693     kriedal1@jhmi.edu    
Principal Investigator: Lisa K Jacobs, M.D.            
Sub-Investigator: Edward W Gabrielson, M.D.            
Sponsors and Collaborators
Diagnostic Photonics, Inc.
Johns Hopkins University
Investigators
Principal Investigator: Lisa K Jacobs, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT01699867     History of Changes
Other Study ID Numbers: DxP 2012-02
Study First Received: October 2, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Diagnostic Photonics, Inc.:
lumpectomy, breast caner, invasive ductal carcinoma, invasive lobular carcinoma, optical coherence tomography, ISAM, tumor margin, imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013