Abstract
AIM: To evaluate reproducibility of pulmonary embolism (PE) clot volume quantification using computed tomography pulmonary angiogram (CTPA) in a multicenter setting. METHODS: This study was performed using anonymized data in conformance with HIPAA and IRB Regulations (March 2015-November 2016). Anonymized CTPA data was acquired from 23 scanners from 18 imaging centers using each site's standard PE protocol. Two independent analysts measured PE volumes using a semi-automated region-growing algorithm on an FDA-approved image analysis platform. Total thrombus volume (TTV) was calculated per patient as the primary endpoint. Secondary endpoints were individual thrombus volume (ITV), Qanadli score and modified Qanadli score per patient. Inter- and intra-observer reproducibility were assessed using intra-class correlation coefficient (ICC) and Bland-Altman analysis. RESULTS: Analyst 1 found 72 emboli in the 23 patients with a mean number of emboli of 3.13 per patient with a range of 0-11 emboli per patient. The clot volumes ranged from 0.0041 - 47.34 cm(3) (mean +/- SD, 5.93 +/- 10.15cm(3)). On the second read, analyst 1 found the same number and distribution of emboli with a range of volumes for read 2 from 0.0041 - 45.52 cm(3) (mean +/- SD, 5.42 +/- 9.53cm(3)). Analyst 2 found 73 emboli in the 23 patients with a mean number of emboli of 3.17 per patient with a range of 0-11 emboli per patient. The clot volumes ranged from 0.00459-46.29 cm(3) (mean +/- SD, 5.91 +/- 10.06 cm(3)). Inter- and intra-observer variability measurements indicated excellent reproducibility of the semi-automated method for quantifying PE volume burden. ICC for all endpoints was greater than 0.95 for inter- and intra-observer analysis. Bland-Altman analysis indicated no significant biases. CONCLUSION: Semi-automated region growing algorithm for quantifying PE is reproducible using data from multiple scanners and is a suitable method for image analysis in multicenter clinical trials.