A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
NCT ID: NCT01372631
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
218 participants
INTERVENTIONAL
2011-04-30
2017-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Pressure assessment
30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
miniature spectral imaging system
Use of miniature spectral imaging system
Bench-top optical spectrometer
Use of bench-top optical spectrometer
Random and Systematic Errors
40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
miniature spectral imaging system
Use of miniature spectral imaging system
Bench-top optical spectrometer
Use of bench-top optical spectrometer
Sensitivity and Specificity Assessment
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
Use of miniature spectral imaging system
Bench-top optical spectrometer
Use of bench-top optical spectrometer
High resolution microendoscope
Use of high resolution microendoscope
Interventions
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miniature spectral imaging system
Use of miniature spectral imaging system
Bench-top optical spectrometer
Use of bench-top optical spectrometer
High resolution microendoscope
Use of high resolution microendoscope
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Nimmi Ramanujam, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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Pro00028284
Identifier Type: -
Identifier Source: org_study_id
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