Fast Spectral Imaging Device for Tumor Margin Mapping
Completed
Conditions studied: Breast Cancer
In brief
The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.
Key facts
- Study ID
- NCT01107080
- Run by
- Duke University
- People needed
- 54
- Starts
- 2009-09-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2013-02-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing a partial mastectomy or 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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