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OpenTrials
Completed

NCT Number: NCT00214292

Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorescence spectroscopy and diffuse spectroscopy

Procedure

Primary outcomes

  1. 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 outcomes

  1. Two potential benefits from developing this technology are:

  2. 1. Decreasing operative times by eliminating the need to wait for histologic margin assessment.

  3. 2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Sep 21, 2005
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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