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Recruiting NCT07730203

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

Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: image acquisition.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other image 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

Primary outcome measures

  • quality of imaging [Time frame: Day of TC acquisition]
Secondary outcome measures (5)
  • evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT [Time frame: immediately after TC acquisition]
  • compare non-catheter urethral contours with catheter-based reference contours [Time frame: immediately after TC acquisition]
  • assess contouring confidence and contouring time across different PCCT reconstruction approaches [Time frame: immediately after TC acquisition]
  • explore segmental urethral visualization along its anatomical course. [Time frame: immediately after TC acquisition]
  • Quantitative contour-derived parameters [Time frame: immediately after TC acquisition]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Humanitas Research Hospital — Rozzano

Publications

  • 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. PMID 40328288
  • 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. PMID 30179101
  • 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. PMID 38234697

Identifiers

NCT: NCT07730203 · PURE-CT/ANTHEM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗