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Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: fluorescence spectroscopy and diffuse spectroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00214292
M-2002-0211
2002-211 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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