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Real Time Optical Coherence Tomography (OCT) of Human Tissue

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ClinicalTrials.gov Identifier: NCT01506700
Recruitment Status : Suspended
First Posted : January 10, 2012
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.

Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Device: Optical Coherence Tomography

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.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Time Optical Coherence Tomography (OCT) of Human Tissue
Study Start Date : May 2012
Estimated Primary Completion Date : February 2019
Study Completion Date : February 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Optical Coherence Tomography
    Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506700


Locations
United States, Illinois
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
Diagnostic Photonics, Inc.
University of Illinois at Chicago
Investigators
Study Chair: Stephen A Boppart, MD, PhD University of Illinois and Diagnostic Photonics, Inc.

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT01506700     History of Changes
Other Study ID Numbers: DXP 2012-01
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018