{"groups":[{"description":"The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015.\n\nStudy Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.","id":"FG000","title":"Device Intervention: Lum Imaging Device Used During Surgery"},{"description":"The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm received the study drug, LUM015.","id":"FG001","title":"Standard of Care Arm"},{"description":"All the patients injected with LUM015 but withdrawn before randomization after standard of care.","id":"FG002","title":"Withdrawn Before Randomization"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Device issue"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"357"},{"groupId":"FG001","numSubjects":"35"},{"groupId":"FG002","numSubjects":"14"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"356"},{"groupId":"FG001","numSubjects":"35"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"406 injected with LUM015 (LUMISIGHT), 14 withdrawn before randomization."}