Spots Global Cancer Trial Database for Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
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Trial Identification
Brief Title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Official Title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Study ID: NCT01699867
Conditions
Interventions
Study Description
Brief Summary: This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Anne Arundel Medical Center, Annapolis, Maryland, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Contact Details
Name: Lisa K Jacobs, M.D.
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
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