Woo Ri Jo1, Seong Hee Kim2, Kyung Won Kim3, Chong Hyun Suh1, Jeong Kon Kim1, Hyosang Kim4, Jong Gu Lee2, Woo Yong Oh2, Seong Eun Choi2, Junhee Pyo5. 1. Department of Radiology, Asan Image Metrics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 2. Clinical Research Division, National Institute of Food and Drug Safety Evaluation, MFDS, Cheong Ju, Republic of Korea. 3. Department of Radiology, Asan Image Metrics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: kyungwon.kim@amc.seoul.kr. 4. Department of Nephrology, Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 5. WHO Collaborating Center for Pharmaceutical Policy and Regulation, Department of Pharmaceutical Science, Utrecht University, Netherlands.
Abstract
PURPOSE: To provide a systematic summary of total kidney volume (TKV) as an imaging biomarker in clinical trials for autosomal dominant polycystic kidney disease (ADPKD), focusing on the correlation between TKV and renal function. METHODS: A computerized literature search was performed using MEDLINE and EMBASE databases for studies that evaluated the correlation between TKV and the glomerular filtration rate (GFR) and between the TKV growth rate and GFR decline rate. A meta-analysis was performed to generate the summary correlation coefficient (r). A qualitative review was performed to evaluate the characteristics of TKV as an imaging biomarker. RESULTS: Eighteen articles including a total sample size of 2835 patients were retrieved. Meta-analysis revealed substantial correlations between TKV and GFR [r, -0.520; 95% confidence interval (CI), -0.60 to -0.43] and between the TKV growth rate and GFR decline rate [r, -0.320; 95% CI, -0.54 to -0.10]. The quantitative review revealed that baseline TKV can affect the TKV growth rate and GFR decline rate, such that patients with a higher baseline TKV showed faster TKV growth and GFR decline. There was significant variability in image acquisition and analysis methods. CONCLUSION: There were significant negative correlations between TKV and GFR as well as between TKV growth and GFR decline rates, suggesting that TKV imaging is a useful biomarker in clinical trials. However, standardization-or at least trial-specific standardization-of image acquisition and analysis techniques is required to use TKV as a reliable biomarker.
PURPOSE: To provide a systematic summary of total kidney volume (TKV) as an imaging biomarker in clinical trials for autosomal dominant polycystic kidney disease (ADPKD), focusing on the correlation between TKV and renal function. METHODS: A computerized literature search was performed using MEDLINE and EMBASE databases for studies that evaluated the correlation between TKV and the glomerular filtration rate (GFR) and between the TKV growth rate and GFR decline rate. A meta-analysis was performed to generate the summary correlation coefficient (r). A qualitative review was performed to evaluate the characteristics of TKV as an imaging biomarker. RESULTS: Eighteen articles including a total sample size of 2835 patients were retrieved. Meta-analysis revealed substantial correlations between TKV and GFR [r, -0.520; 95% confidence interval (CI), -0.60 to -0.43] and between the TKV growth rate and GFR decline rate [r, -0.320; 95% CI, -0.54 to -0.10]. The quantitative review revealed that baseline TKV can affect the TKV growth rate and GFR decline rate, such that patients with a higher baseline TKV showed faster TKV growth and GFR decline. There was significant variability in image acquisition and analysis methods. CONCLUSION: There were significant negative correlations between TKV and GFR as well as between TKV growth and GFR decline rates, suggesting that TKV imaging is a useful biomarker in clinical trials. However, standardization-or at least trial-specific standardization-of image acquisition and analysis techniques is required to use TKV as a reliable biomarker.
Authors: Charlotte Gimpel; E Fred Avni; Luc Breysem; Kathrin Burgmaier; Anna Caroli; Metin Cetiner; Dieter Haffner; Erum A Hartung; Doris Franke; Jens König; Max C Liebau; Djalila Mekahli; Albert C M Ong; Lars Pape; Andrea Titieni; Roser Torra; Paul J D Winyard; Franz Schaefer Journal: Radiology Date: 2019-01-01 Impact factor: 11.105
Authors: Charlotte Gimpel; Carsten Bergmann; Detlef Bockenhauer; Luc Breysem; Melissa A Cadnapaphornchai; Metin Cetiner; Jan Dudley; Francesco Emma; Martin Konrad; Tess Harris; Peter C Harris; Jens König; Max C Liebau; Matko Marlais; Djalila Mekahli; Alison M Metcalfe; Jun Oh; Ronald D Perrone; Manish D Sinha; Andrea Titieni; Roser Torra; Stefanie Weber; Paul J D Winyard; Franz Schaefer Journal: Nat Rev Nephrol Date: 2019-11 Impact factor: 28.314