Fast Spectral Imaging Device for Tumor Margin Mapping
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Fast Spectral Imaging Device for Tumor Margin Mapping|
- To perform a critical evaluation of the device in a practical clinical setting [ Time Frame: 2 years ] [ Designated as safety issue: No ](1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.
|Study Start Date:||September 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes.
25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107080
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Nimmi Ramanujam, PhD||Duke University|