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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699867
• Other study ID #: DxP 2012-02 (Part A)
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: December 12, 2014
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Diagnostic Photonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: May 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 informed consent form

3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery

4. Patients planning breast preservation and 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Optical coherence tomography
Optical coherence tomography was used to image ex vivo breast tissue specimens.

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Diagnostic Photonics, Inc.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of Margins With False Positive Device Readings		one week after surgery	No