NCT07730203|Recruiting
Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM
PURE-CT/ANTHEM
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PURE-CT/ANTHEM
Sponsor study identifier
observational
20
1 country
1
Study Start
June 22, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body. If the urethra receives too much radiation, patients may experience urinary side effects. Current CT scans used for treatment planning do not clearly show the urethra unless a urinary catheter is inserted. While a catheter can improve visibility, it may cause discomfort, increase the risk of infection, and slightly change the natural position of the urethra. MRI scans can also help visualize the urethra, but they are not always available and may not fit easily into all treatment workflows. Photon-counting CT (PCCT) is a new type of CT scanner that produces higher-quality images with better detail. This technology may allow doctors to see the urethra without using a catheter. The purpose of this pilot study is to investigate whether PCCT can reliably visualize the urethra in prostate cancer patients without the need for catheter insertion. If successful, this approach could make treatment planning more comfortable and less invasive while helping doctors better protect healthy tissues during radiotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2026
Actual (reported)June 24, 2026
Actual (reported)July 28, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
quality of imaging
Quantitative quality of prostatic urethra contouring on non-catheter photon-counting CT, assessed using spatial overlap and boundary agreement metrics, specifically the Dice similarity coefficient (DSC) and the 95th percentile Hausdorff distance (HD95), with corresponding confidence intervals.
Day of TC acquisition
evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT
immediately after TC acquisition
compare non-catheter urethral contours with catheter-based reference contours
immediately after TC acquisition
assess contouring confidence and contouring time across different PCCT reconstruction approaches
immediately after TC acquisition
explore segmental urethral visualization along its anatomical course.
immediately after TC acquisition
Quantitative contour-derived parameters
immediately after TC acquisition
Two sets of images will be acquired on TC photon counting: the first without a catheter, and the second after catheter placement by healthcare personnel. Comparison between images with and without catheter
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patient with prostate cancer with indication to radiotherapy treatment
IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089, Italy
Shah KD, Zhou J, Roper J, Dhabaan A, Al-Hallaq H, Pourmorteza A, Yang X. Photon-counting CT in cancer radiotherapy: technological advances and clinical benefits. Phys Med Biol. 2025 May 16;70(10):10TR01. doi: 10.1088/1361-6560/add4ba.
Willemink MJ, Persson M, Pourmorteza A, Pelc NJ, Fleischmann D. Photon-counting CT: Technical Principles and Clinical Prospects. Radiology. 2018 Nov;289(2):293-312. doi: 10.1148/radiol.2018172656. Epub 2018 Sep 4.
First Submitted
June 24, 2026
First Posted
July 28, 2026
Study Start
June 22, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Yoshimura T, Okubo K, Takase Y, et al. Visualizing the urethra by magnetic resonance imaging without catheterization: Post-urination MRI technique. European Journal of Radiology Open. 2021 Jul;8:100382
Ong WL, Allan Hupman M, Davidson M, Ruschin M, Detsky J, Liu S, Vesprini D, Loblaw A. Urethra contouring on computed tomography urethrogram versus magnetic resonance imaging for stereotactic body radiotherapy in prostate cancer. Clin Transl Radiat Oncol. 2023 Dec 30;45:100722. doi: 10.1016/j.ctro.2023.100722. eCollection 2024 Mar.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 28, 2026
Record last verified: 2026-06
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