Real Time Optical Coherence Tomography (OCT) of Human Tissue

Breast Cancer Clinical Trial

Official title:

Real Time Optical Coherence Tomography (OCT) of Human Tissue

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01506700
• Other study ID #: DXP 2012-01
• Status: Terminated
• Start date: May 2012
• Est. completion date: July 17, 2019

Study information

• Verified date: July 2019
• Source: Diagnostic Photonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 17, 2019
• Est. primary completion date: December 20, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Diagnostic Photonics, Inc.	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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