Breast Cancer
Conditions
Keywords
Reduction mammoplasty, mastectomy, partial mastectomy, lumpectomy, breast conserving surgery, breast cancer
Brief summary
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.
Detailed description
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.
Interventions
DEVICEminiature spectral imaging system
Use of miniature spectral imaging system
DEVICEBench-top optical spectrometer
Use of bench-top optical spectrometer
Use of high resolution microendoscope
Sponsors
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a reduction mammoplasty OR * Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy * Age \> 18 * Clinically detectable disease either by physical examination or radiographic studies * Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Patients considered in vulnerable populations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of the optical signatures in breast tissue | Day of procedure (less than 10 minutes) |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and Specificity of the device | Day of procedure (less than 10 minutes) |
Countries
United States
Outcome results
None listed