Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

Breast Cancer Clinical Trial

Official title:

A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In Situ of the Breast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214292
• Other study ID #: M-2002-0211
• Secondary ID: 2002-211
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: January 28, 2016
• Start date: May 2005
• Est. completion date: March 2011

Study information

• Verified date: January 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will apply optical spectroscopy to intraoperative margin assessment during surgery for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ductal carcinoma in-situ or invasive carcinoma diagnosed by image directed core biopsy who are planning to undergo breast conserving surgery

Exclusion Criteria:

• patients who were diagnosed with excisional biopsy and patients undergoing mastectomy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Procedure:
• fluorescence spectroscopy and diffuse spectroscopy

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The goal of this research is to develop a minimally invasive technology with the capability of rapidly assessing surgical margins for breast cancer patients undergoing breast conserving therapy.
Secondary	Two potential benefits from developing this technology are:
Secondary	1. Decreasing operative times by eliminating the need to wait for histologic margin assessment.
Secondary	2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists.