{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.4","upperLimit":"99.5","value":"80.0"},{"groupId":"OG001","lowerLimit":"47.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"0.5","upperLimit":"71.6","value":"20.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"0.0","upperLimit":"97.5","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"description":"The diagnostic performance of \\[68Ga\\]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens.\n\nSince the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on \\[68Ga\\]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on \\[68Ga\\]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).","dispersionType":"95% Confidence Interval","groups":[{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG000","title":"Breast"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG001","title":"Prostate"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG002","title":"Colorectal"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG003","title":"Non-Small Cell Lung Cancer (NSCLC)"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG004","title":"Small-Cell Lung Cancer (SCLC)"}],"paramType":"NUMBER","populationDescription":"Full Analysis Set (FAS). The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.","reportingStatus":"POSTED","timeFrame":"Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1","title":"Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence","type":"SECONDARY","unitOfMeasure":"Percent agreement"}