Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

NCT02313116 | Suspended

• 1 other identifier: DxP 2012-02 (Part B)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

Conditions

Breast Cancer

Keywords

Lumpectomy; Breast cancer; Optical coherence tomography; Tumor margin; Imaging

Outcome Measures

Primary Outcomes (2)

• Patients With All Positive/Close Margins Correctly Identified With the Device

  1 week after surgery

• Number of Margins With False Positive Device Readings

  1 week after surgery

Interventions

Interferometric Synthetic Aperture Microscopy DEVICE

Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.

Also known as: Optical Coherence Tomography

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

Women with breast cancer undergoing lumpectomy.

You may qualify if:

• Women 18 years of age or older
• Signed informed consent form
• Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
• Patients planning breast preservation and 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

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, 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

• Lisa Jacobs

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2020
• Study Completion: March 18, 2020
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)