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Completed

NCT Number: NCT00734838

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

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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

Duke University Medical Center

Durham, North Carolina, 27708, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients having a needle biopsy of a breast mass

Exclusion criteria

  • none

Treatment and study plan

High resolution microendoscope

Device

Using core biopsy and reduction mammoplasty tissue

Primary outcomes

  1. Optical signatures

    Time frame: Day of procedure (less than 10 minutes)

    The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • William Marsh Rice University

Registry information

Important dates

Study start
2006
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2008
Registry last updated
Aug 14, 2023

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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