About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prostate cancer candidate to radiotherapy
Written informed consent.
Eligibility for urethral catheter placement according to institutional practice
Disqualifiers
Active or suspected urinary tract infection.
Known urethral stricture or recent urethral surgery
Contraindication to catheter placement.
Trial population
patient with prostate cancer with indication to radiotherapy treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
image acquisition
Other interventionTwo 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT
Inter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).
compare non-catheter urethral contours with catheter-based reference contours
Agreement between non-catheter and catheter-based contours using spatial and geometric metrics (DSC and HD95).
assess contouring confidence and contouring time across different PCCT reconstruction approaches
Contour confidence score and contour time compared to standardized clinical times
explore segmental urethral visualization along its anatomical course.
evaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization
Sponsors and contacts
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