IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089, Italy
Location status: Recruiting
Location contact
Ciro Franzese, MD, Radiation Oncologist
CONTACT
Laura Bonavita, Master degree
CONTACT
NCT Number: NCT07730203
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Rozzano, Milan, 20089, Italy
Location status: Recruiting
Ciro Franzese, MD, Radiation Oncologist
CONTACT
Laura Bonavita, Master degree
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: immediately after TC acquisition
Inter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).
Time frame: immediately after TC acquisition
Agreement between non-catheter and catheter-based contours using spatial and geometric metrics (DSC and HD95).
Time frame: immediately after TC acquisition
Contour confidence score and contour time compared to standardized clinical times
Time frame: immediately after TC acquisition
evaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization
Time frame: immediately after TC acquisition
explore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility
Contact information is provided by the study sponsor or research team.
Ciro Franzese, MD, Radiation Oncologist
CONTACT
Laura Bonavita, Master degree
CONTACT
Istituto Clinico Humanitas
Other
Acronym: PURE-CT/ANTHEM
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.
Published trials that share one or more normalized conditions with this study.
NCT01441089
Adnexal Diseases, Breast Cancer
Bethesda, Maryland, United States
View Trial DetailsNCT01834001
Genital Diseases, Genital Diseases, Male
Bethesda, Maryland, United States
View Trial DetailsNCT00923221
Cancer Of Prostate, Genital Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT00034216
Breast Cancer, Breast Diseases
Bethesda, Maryland, United States
View Trial Details