TABLE 1

FDA-Approved Imaging Drugs with Effectiveness Data from Published Reports

18F-FDGRecurrent prostate cancer
Published dataCardiacOncologic13N-ammonia (cardiac)11C-choline18F-fluciclovine68Ga-DOTATATE (SSR+ NET)
Selection criteriaTruth standard and imaging outcome established for each patient Prospective Patient characteristics described Image interpretation methods described Truth standard detailed for each patient Methods for minimizing bias applied (e.g., masking, description of any patient or image selection bias)Images compared with pathology truth standard Prospective Eligibility criteria defining clinically applicable patient population described Endpoints clearly defined Data on study findings detailed Methods for minimizing bias applied (e.g., masking, randomization, multiple independent interpreters) Sample > 50Images compared with truth standard of accepted myocardial perfusion method or coronary arteriography Prospective Endpoints clearly defined Eligibility criteria defined for clinically applicable patient population Study results detailed Methods for minimizing bias applied (e.g., masking, randomization)Prospective or retrospective Patient disposition adequately described Images compared with pathology truth standard Measures to control bias in image interpretation described Study drug dose described Analytic procedure described Noninformative conventional imaging results Sample ≥ 10Site images available for reinterpretation Site data available for reanalysisProspective or retrospective Patient disposition adequately described Images compared with truth standard of histopathology or clinical follow-up Image interpretation described
Studies (n)10 meeting all criteria2 meeting all criteria; 16 variably meeting criteria1 meeting all criteria; 3 meeting all criteria except retrospective design2 prospective and 2 retrospective2 prospective2 retrospective
Patients (n)2981,311 (including 155 in the studies meeting all criteria)293 (including 193 in study meeting all criteria)98201167
ObservationsSensitivity and specificitySensitivity and specificitySensitivity and specificitySensitivity and specificityT/F positives and negatives; agreement with comparatorT/F positives and negatives
  • SSR+ NET = somatostatin receptor–positive neuroendocrine tumor; T/F = true and false.