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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02313116
• Other study ID #: DxP 2012-02 (Part B)
• Status: Suspended
• Start date: April 2014
• Est. completion date: March 18, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: March 18, 2020
• Est. primary completion date: February 2020
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Interferometric Synthetic Aperture Microscopy
Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Diagnostic Photonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With All Positive/Close Margins Correctly Identified With the Device		1 week after surgery
Primary	Number of Margins With False Positive Device Readings		1 week after surgery