Computed Optical Margin Assessment for Breast Cancer Surgery
This study is a multi-center, prospective, open label study of approximately fifty (50) subjects at two (2) study sites, Johns Hopkins Hospital and Anne Arundel Medical Center. Patients scheduled to undergo lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue samples using the study device during their lumpectomy.
This trial compares intraoperative imaging analysis of breast tumor margins to results from post-operative histology. The study will evaluate the ability to identify margin status (sensitivity and specificity) of intraoperative imaging vs. final pathology.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Computed Optical Margin Assessment for Breast Cancer Surgery|
- Ex vivo ISAM sensitivity and specificity [ Time Frame: one week after surgery ] [ Designated as safety issue: No ]The sensitivity and specificity of intraoperative imaging analysis to identify tumor on surgical specimen margins ex vivo when compared to blinded post-surgical histology findings.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Device: Interferometric Synthetic Aperture Microscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699867
|Contact: Karyn Rhyder, RNfirstname.lastname@example.org|
|United States, Maryland|
|Anne Arundel Medical Center||Not yet recruiting|
|Annapolis, Maryland, United States, 21401|
|Contact: Kristen Sawyer, M.S. 443-481-5749 email@example.com|
|Sub-Investigator: Lorraine Tafra, M.D.|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Karyn Rhyder, R.N. 410-502-9693 firstname.lastname@example.org|
|Principal Investigator: Lisa K Jacobs, M.D.|
|Sub-Investigator: Edward W Gabrielson, M.D.|
|Principal Investigator:||Lisa K Jacobs, M.D.||Johns Hopkins University|