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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07730203
Acronym
PURE-CT/ANTHEM
Enrollment
20
Registered
2026-07-28
Start date
2026-06-22
Completion date
2026-12-31
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, urethra, radiotherapy treatment

Brief summary

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

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

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
quality of imagingDay of TC acquisitionQuantitative 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

MeasureTime frameDescription
evaluate inter-observer agreement of urethral contours generated on non-catheter PCCTimmediately after TC acquisitionInter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).
compare non-catheter urethral contours with catheter-based reference contoursimmediately after TC acquisitionAgreement 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 approachesimmediately after TC acquisitionContour confidence score and contour time compared to standardized clinical times
explore segmental urethral visualization along its anatomical course.immediately after TC acquisitionevaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization
Quantitative contour-derived parametersimmediately after TC acquisitionexplore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility

Countries

Italy

Contacts

CONTACTCiro Franzese, MD, Radiation Oncologist
ciro.franzese@hunimed.eu+39 0282247454
CONTACTLaura Bonavita, Master degree
laura.bonavita@humanitas.it+39 0282247026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026