Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Duke University

Status: Completed

Conditions: Breast Cancer

Treatments: Device: High Resolution Microendoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT00734838

W81XWH-09-1-0410 (Other Grant/Funding Number)

NIH 5R01-CA-100559

Pro00008003

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients having a needle biopsy of a breast mass

Exclusion criteria

• none

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups, including a placebo group

Core needle biopsy

Experimental group

Description:

Patients needing a needle biopsy of a breast mass

Treatment:

Device: High Resolution Microendoscope

Reduction mammoplasty

Placebo Comparator group

Description:

Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer

Treatment:

Device: High Resolution Microendoscope