Published online Oct 28, 2018. doi: 10.4329/wjr.v10.i10.124
Peer-review started: June 1, 2018
First decision: July 23, 2018
Revised: July 27, 2018
Accepted: August 4, 2018
Article in press: August 4, 2018
Published online: October 28, 2018
Processing time: 148 Days and 8.4 Hours
To evaluate reproducibility of pulmonary embolism (PE) clot volume quantification using computed tomography pulmonary angiogram (CTPA) in a multicenter setting.
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.
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 cm3 (mean +/- SD, 5.93 +/- 10.15cm3). 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 cm3 (mean +/- SD, 5.42 +/- 9.53cm3). 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 cm3 (mean +/- SD, 5.91 +/- 10.06 cm3). 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.
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.
Core tip: Blood clots that occur in deep leg veins can break away and cause the serious complication of clots (then termed emboli) lodged in the lungs. Measuring the volume of the emboli with a semi-automated region growing software program using computed tomography pulmonary angiogram data can be helpful to evaluate treatment efficacy in clinical drug trials. This study demonstrates the technique to be reproducible both between image analysts and when repeated by the same image analyst when the data is obtained in a multicenter setting.