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

NCT01699867 | Completed Results

• 1 other identifier: DxP 2012-02 (Part A)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after 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 Margins Correctly Identified With the Device

  In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").

  one week after surgery

• Number of Margins With False Positive Device Readings

  one week after surgery

Interventions

Optical coherence tomography DEVICE

Optical coherence tomography was used to image ex vivo breast tissue 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

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
• Johns Hopkins University: collaborator

Study Sites (2)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

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

Results Point of Contact

• Title: Lisa K. Jacobs, M.D.
• Organization: Johns Hopkins Medicine

ljacob14@jhmi.edu

410-502-0880

Study Officials

• Lisa K Jacobs, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 6, 2015
• Results First Posted: December 12, 2014

Record last verified: 2014-12

Locations

US (2)