Real Time Optical Coherence Tomography (OCT) of Human Tissue

NCT01506700 | Terminated

• 1 other identifier: DXP 2012-01
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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.

  One week after surgery

Interventions

Optical Coherence Tomography DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females with breast cancer

You may qualify if:

• Women 18 years of age or older
• Signed ICF
• Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery
• Planning breast preservation
• Patients undergoing lumpectomy (partial mastectomy) procedure

You may not qualify if:

• Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Neoadjuvant systemic therapy
• All T4 tumors
• Previous radiation in the operated breast
• Prior surgical procedure in the same quadrant
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Sponsors & Collaborators

• Diagnostic Photonics, Inc.: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Stephen A Boppart, MD, PhD

  University of Illinois and Diagnostic Photonics, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: May 1, 2012
• Primary Completion: December 20, 2013
• Study Completion: July 17, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

US (1)