Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients needing a needle biopsy of a breast mass

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

Using core biopsy and reduction mammoplasty tissue

High Resolution Microendoscope

Nimmi Ramanujam, PhD

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.

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

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

William Marsh Rice University

Duke University

30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.

40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.

150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.

miniature spectral imaging system

Bench-top optical spectrometer

High resolution microendoscope

Nimmi Ramanujam, Ph.D.

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.

Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy	NCT00734838	Breast Cancer	High Resolution...	18 Years -	Duke University
A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins	NCT01372631	Breast Cancer	miniature spect... Bench-top optic... High resolution...	18 Years -	Duke University
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy	NCT00734838	Breast Cancer	High Resolution...	18 Years -	Duke University

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