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Real Time Optical Coherence Tomography (OCT) of Human Tissue

This study is currently recruiting participants.
Verified August 2012 by Diagnostic Photonics, Inc.
Sponsor:
Collaborator:
University of Illinois
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier:
NCT01506700
First received: January 6, 2012
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.


Condition Intervention
Breast Cancer
 Device: Optical Coherence Tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Time Optical Coherence Tomography (OCT) of Human Tissue

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions. [ Time Frame: One week after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Optical Coherence Tomography
    Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.
Detailed Description:

This study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to undergo a 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 in vivo and ex vivo breast tissue samples using the study device during their lumpectomy.

All specimens will be marked with India ink and undergo standard post-operative histology, and digital histology images corresponding to the inked locations will be obtained. The images and the matched digitized post-operative histology images will then be randomized and read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.

  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

Females with breast cancer

Criteria

Inclusion Criteria:

  1. Women 18 years of age or older
  2. Signed ICF
  3. Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery
  4. Planning breast preservation
  5. Patients 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: NCT01506700

Contacts
Contact: Barbara Hall, BS 217-383-6199 Barbara.Hall@carle.com

Locations
United States, Illinois
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Barbara Hall, BS     217-383-6199     Barbara.Hall@carle.com    
Sub-Investigator: Kimberley Cradock, MD            
Principal Investigator: Partha Ray, MD            
Sponsors and Collaborators
Diagnostic Photonics, Inc.
University of Illinois
Investigators
Study Chair: Stephen A Boppart, MD, PhD University of Illinois and Diagnostic Photonics, Inc.
  More Information

No publications provided

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT01506700     History of Changes
Other Study ID Numbers: DXP 2012-01
Study First Received: January 6, 2012
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013