Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorIstituto Clinico Humanitas

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • image acquisition

    Other intervention

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Day of TC acquisition

Secondary outcomes

1

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).

Time frame
immediately after TC acquisition
2

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).

Time frame
immediately after TC acquisition
3

assess contouring confidence and contouring time across different PCCT reconstruction approaches

Contour confidence score and contour time compared to standardized clinical times

Time frame
immediately after TC acquisition
4

explore segmental urethral visualization along its anatomical course.

evaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization

Time frame
immediately after TC acquisition

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.