Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

NCT ID: NCT00214292

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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fluorescence spectroscopy and diffuse spectroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tara Breslin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2002-211

Identifier Type: OTHER

Identifier Source: secondary_id

M-2002-0211

Identifier Type: -

Identifier Source: org_study_id

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