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Evaluation of the Total Kidney Volume AI Algorithm
Rochester, Minn.
The natural course of autosomal dominant polycystic kidney disease (ADPKD) is highly variable and typically characterized by progressive enlargement of cysts within the kidneys. ADPKD is a leading cause of end-stage renal disease. Recently, a new medication called Tolvaptan has been approved by the FDA to slow progression of ADPKD. Accurate, MR based kidney volume measurements are the best parameter for following the progression of ADPKD, and are suggested be acquired to measure progression and effects of Tolvaptan. However, making these slice-by-slice volume measurements can be extremely time consuming when done manually. The purpose of this work is to evaluate an AI algorithm to make the measurements. The results of the algorithm will be reviewed by a qualified radiologist familiar with the algorithm’s results. If the radiologist agrees with the results, kidney volumes (left, right and combined) will be recorded for clinical use. The usage of the algorithm in this setting (with review by radiologist, and manual correction) is a minimal risk to the patients: a failure of the algorithm will have no impact on treatment and errors will be caught and corrected by the QC process. Because the algorithm will not be used solely for diagnosis or inform treatment without the confirmation of the diagnosis by another, medically established diagnostic product or procedure this study constitutes minimal risk to patients.
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