Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Duke University213 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

213

Conditions

Breast Cancer

Interventions

Using core biopsy and reduction mammoplasty tissue

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients having a needle biopsy of a breast mass Exclusion Criteria: * none

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Optical signatures

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

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

Data from ClinicalTrials.gov

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