A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
2 other identifiers
interventional
218
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Apr 2011
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 12, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFebruary 10, 2021
June 1, 2020
6 years
June 12, 2011
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of the optical signatures in breast tissue
Day of procedure (less than 10 minutes)
Secondary Outcomes (1)
Sensitivity and Specificity of the device
Day of procedure (less than 10 minutes)
Study Arms (3)
Pressure assessment
EXPERIMENTAL30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
Random and Systematic Errors
EXPERIMENTAL40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
Sensitivity and Specificity Assessment
EXPERIMENTAL150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.
Interventions
Use of miniature spectral imaging system
Use of bench-top optical spectrometer
Use of high resolution microendoscope
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients considered in "vulnerable" populations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Duke University Medical Center
Durham, North Carolina, 27708, United States
University of Wisconsin - Madison
Madison, Wisconsin, 54706, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nimmi Ramanujam, Ph.D.
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2011
First Posted
June 14, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
February 10, 2021
Record last verified: 2020-06