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NCT Number: NCT07730203

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prostate cancer candidate to radiotherapy
  • Written informed consent.
  • Eligibility for urethral catheter placement according to institutional practice

Exclusion criteria

  • Active or suspected urinary tract infection.
  • Known urethral stricture or recent urethral surgery
  • Contraindication to catheter placement.

Treatment and study plan

Image acquisition

Other

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

Primary outcomes

  1. quality of imaging

    Time frame: Day of TC acquisition

    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

  1. evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT

    Time frame: immediately after TC acquisition

    Inter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).

  2. compare non-catheter urethral contours with catheter-based reference contours

    Time frame: immediately after TC acquisition

    Agreement between non-catheter and catheter-based contours using spatial and geometric metrics (DSC and HD95).

  3. assess contouring confidence and contouring time across different PCCT reconstruction approaches

    Time frame: immediately after TC acquisition

    Contour confidence score and contour time compared to standardized clinical times

  4. explore segmental urethral visualization along its anatomical course.

    Time frame: immediately after TC acquisition

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

  5. Quantitative contour-derived parameters

    Time frame: immediately after TC acquisition

    explore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility

Study contacts

Contact information is provided by the study sponsor or research team.

Ciro Franzese, MD, Radiation Oncologist

CONTACT

[email protected]

+39 0282247454

Laura Bonavita, Master degree

CONTACT

[email protected]

+39 0282247026

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: PURE-CT/ANTHEM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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