Real Time Optical Coherence Tomography (OCT) of Human Tissue

NCT ID: NCT01506700

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2019-07-17

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Optical Coherence Tomography

Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Diagnostic Photonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen A Boppart, MD, PhD

Role: STUDY_CHAIR

University of Illinois and Diagnostic Photonics, Inc.

Locations

Carle Foundation Hospital

Urbana, Illinois, United States

Countries

United States

Other Identifiers

DXP 2012-01

Identifier Type: -

Identifier Source: org_study_id