Nancy A. Obuchowski

Yan Liu, Huitian Xia, Nancy A. Obuchowski et al.

Quantitative imaging (QI) is demonstrating strong promise across multiple clinical applications. For clinical translation of QI methods, objective evaluation on clinically relevant tasks is essential. To address this need, multiple evaluation strategies are being developed. In this paper, based on previous literature, we outline four emerging frameworks to perform evaluation studies of QI methods. We first discuss the use of virtual imaging trials (VITs) to evaluate QI methods. Next, we outline a no-gold-standard evaluation framework to clinically evaluate QI methods without ground truth. Third, a framework to evaluate QI methods for joint detection and quantification tasks is outlined. Finally, we outline a framework to evaluate QI methods that output multi-dimensional parameters, such as radiomic features. We review these frameworks, discussing their utilities and limitations. Further, we examine future research areas in evaluation of QI methods. Given the recent advancements in PET, including long axial field-of-view scanners and the development of artificial-intelligence algorithms, we present these frameworks in the context of PET.

Anindo Saha, Joeran S. Bosma, Jasper J. Twilt et al.

In this intercontinental, confirmatory study, we include a retrospective cohort of 22,481 MRI examinations (21,288 patients; 46 cities in 22 countries) to train and externally validate the PI-CAI-2B model, i.e., an efficient, next-generation iteration of the state-of-the-art AI system that was developed for detecting Gleason grade group $\geq$2 prostate cancer on MRI during the PI-CAI study. Of these examinations, 20,471 cases (19,278 patients; 26 cities in 14 countries) from two EU Horizon projects (ProCAncer-I, COMFORT) and 12 independent centers based in Europe, North America, Asia and Africa, are used for training and internal testing. Additionally, 2010 cases (2010 patients; 20 external cities in 12 countries) from population-based screening (STHLM3-MRI, IP1-PROSTAGRAM trials) and primary diagnostic settings (PRIME trial) based in Europe, North and South Americas, Asia and Australia, are used for external testing. Primary endpoint is the proportion of AI-based assessments in agreement with the standard of care diagnoses (i.e., clinical assessments made by expert uropathologists on histopathology, if available, or at least two expert urogenital radiologists in consensus; with access to patient history and peer consultation) in the detection of Gleason grade group $\geq$2 prostate cancer within the external testing cohorts. Our statistical analysis plan is prespecified with a hypothesis of diagnostic interchangeability to the standard of care at the PI-RADS $\geq$3 (primary diagnosis) or $\geq$4 (screening) cut-off, considering an absolute margin of 0.05 and reader estimates derived from the PI-CAI observer study (62 radiologists reading 400 cases). Secondary measures comprise the area under the receiver operating characteristic curve (AUROC) of the AI system stratified by imaging quality, patient age and patient ethnicity to identify underlying biases (if any).