Abstract
Background
No previous research papers have reported a comparative survey of local radiologic diagnoses and central review in children with hepatoblastoma.
Objective
To evaluate the utility of central review of children with hepatoblastoma enrolled in a clinical trial.
Materials and methods
The study included 91 children enrolled in a clinical trial conducted by the Japanese Study Group for Pediatric Liver Tumor. We compared the results of the initial pre-treatment extent of tumor (PRETEXT) disease staging performed at local sites with the results obtained on central review to determine the concurrence rates for tumor staging and additional criteria.
Results
The concurrence rate for PRETEXT staging was 70%. As the stage increased, the concurrence rate decreased. Using additional criteria, central review identified 143 lesions (157.1%), about 1.8 times higher than the number identified for the local site diagnoses. The additional criterion found most often on central review was “multifocal lesion” (n=19). The concurrence rate for lung metastases was high. However, our central review found many false-positive assertions of hepatic vein lesions, portal vein invasion and extrahepatic lesions among the local site diagnoses.
Conclusion
In a clinical trial of hepatoblastoma, central review provided a more precise diagnosis than local site diagnoses with respect to severe PRETEXT stages III and IV cases and other cases including hepatic and portal vein invasion. The central review process appears to be effective and essential for improving the quality of clinical trials.
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Acknowledgments
The authors would like to thank Dr. Yoshitomo Matsuo and Ban Asatsuma for technical support with respect to a cloud-based teleradiology system (Esite Healthcare Co., Tokyo, Japan). The authors appreciate the contributions made by all of the physician members of the Japan Children’s Cancer Group (JCCG) and liver tumor committee. We thank Mrs. Hiroe Saito, Mrs. Rika Kashihara and Mrs. Minako Mase for office work in the radiology committee of the JCCG. This work was supported by the Japan Agency for Medical Research and Development (AMED) under grant numbers 17ck0106332h, 20ck0106609h and 20lk0201066h, and the Japanese Society for the Promotion of Science (JSPS KAKENHI) under grant number JP16H02778.
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Miyazaki, O., Oguma, E., Nishikawa, M. et al. Usefulness of central radiologic review in clinical trials of children with hepatoblastoma. Pediatr Radiol 53, 367–377 (2023). https://doi.org/10.1007/s00247-022-05530-4
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DOI: https://doi.org/10.1007/s00247-022-05530-4