Real Time Optical Coherence Tomography (OCT) of Human Tissue

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01506700
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Study Start: 2012-05
• Primary Completion: 2013-12-20
• Status Verified: 2019-07
• Study Completion: 2019-07-17
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	One week after surgery

Trial Locations

Locations (1)

Carle Foundation Hospital; 🇺🇸 Urbana, Illinois, United States