Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM (PURE-CT/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.
Studieoversikt
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ciro Franzese, MD, Radiation Oncologist
- Telefonnummer: +39 0282247454
- E-post: ciro.franzese@hunimed.eu
Studer Kontakt Backup
- Navn: Laura Bonavita, Master degree
- Telefonnummer: +39 0282247026
- E-post: laura.bonavita@humanitas.it
Studiesteder
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Milan
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Rozzano, Milan, Italia, 20089
- Rekruttering
- Irccs Humanitas Research Hospital
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Ta kontakt med:
- Ciro Franzese, MD, Radiation Oncologist
- Telefonnummer: +39 0282247454
- E-post: ciro.franzese@hunimed.eu
-
Ta kontakt med:
- Laura Bonavita, Master degree
- Telefonnummer: +39 0282247026
- E-post: laura.bonavita@humanitas.it
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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quality of imaging
Tidsramme: Day of TC acquisition
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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.
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Day of TC acquisition
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT
Tidsramme: immediately after TC acquisition
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Inter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).
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immediately after TC acquisition
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compare non-catheter urethral contours with catheter-based reference contours
Tidsramme: immediately after TC acquisition
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Agreement between non-catheter and catheter-based contours using spatial and geometric metrics (DSC and HD95).
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immediately after TC acquisition
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assess contouring confidence and contouring time across different PCCT reconstruction approaches
Tidsramme: immediately after TC acquisition
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Contour confidence score and contour time compared to standardized clinical times
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immediately after TC acquisition
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explore segmental urethral visualization along its anatomical course.
Tidsramme: immediately after TC acquisition
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evaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization
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immediately after TC acquisition
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Quantitative contour-derived parameters
Tidsramme: immediately after TC acquisition
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explore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility
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immediately after TC acquisition
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PURE-CT/ANTHEM
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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