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Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214292
First received: September 14, 2005
Last updated: July 15, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Procedure: fluorescence spectroscopy and diffuse spectroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In Situ of the Breast

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Two potential benefits from developing this technology are:
  • 1. Decreasing operative times by eliminating the need to wait for histologic margin assessment.
  • 2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists.

Estimated Enrollment: 20
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214292

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Tara Breslin, MD University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214292     History of Changes
Other Study ID Numbers: M-2002-0211
Study First Received: September 14, 2005
Last Updated: July 15, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 23, 2013