{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.5","upperLimit":"88.3","value":"86.5"}]}]}],"denomUnitsSelected":"Negative margins without cancer","denoms":[{"counts":[{"groupId":"OG000","value":"357"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"2277"}],"units":"Negative margins without cancer"}],"description":"Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity was measured as percentage of the negative margins without cancer, that were tested negative by LUM Imaging System. The estimate of the instrument diagnostic specificity used Generalized Estimating Equations (GEE) approach with random effects from intraclass correlation within subjects.","dispersionType":"95% Confidence Interval","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":"OG000","title":"Device Intervention: LUM Imaging System Used During Surgery"}],"paramType":"NUMBER","populationDescription":"modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed","reportingStatus":"POSTED","timeFrame":"Day 1, during surgery","title":"Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity","type":"PRIMARY","typeUnitsAnalyzed":"Negative margins without cancer","unitOfMeasure":"percentage of negative margins w/o ca"}