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OpenTrials
Completed

NCT Number: NCT06168864

Development of Artificial Intelligence Models for Segmentation and Characterization of Prostate Cancer: a Single-center Retrospective Observational Study.

Prostate cancer is the second most common cancer in the male population. This pathology represents an oncological and public health problem especially in developed countries, due to a greater presence of elderly men in the population.

Medical imaging plays a central role in the staging and restaging of prostate disease. Magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) are among the methods commonly used in normal clinical practice for the characterization of prostate cancer. To date, the study of these images is limited to a qualitative visual analysis, however there is increasing evidence relating to the usefulness of introducing a quantitative (or semi-quantitative) analysis of biomedical images.

The current increase in available imaging data, and their quality, allows the application of artificial intelligence methods also in the medical field for the automation of tasks (e.g. automatic segmentation) and classification (e.g. tumor aggressiveness).

The extraction of quantitative data, and more generally the study of tumor lesions, requires manual segmentation by one or more doctors. This process requires very long times as each image must be processed individually; furthermore, the result also depends on the level of experience of the doctor carrying out the segmentation and this could create a source of heterogeneity, affecting the reproducibility of the segmentation.

AI-based automatic segmentation methods can be applied to medical images for the localization of tumor lesions, thus exceeding the limits of manual segmentation.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Irccs San Raffaele

Milan, 20132, Italy

Who can participate

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

Inclusion criteria

  • Patients with histological diagnosis of prostate cancer;
  • Patients who performed a PET exam with 68 Ga-PMSA.

Exclusion criteria

  • CT and MR images with artifacts that preclude interpretation of results.

Treatment and study plan

Artificial intelligence models for segmentation and characterization of prostate cancer

Diagnostic Test

rtificial intelligence algorithms for the automatic segmentation of prostate cancer lesions on medical images.

Primary outcomes

  1. Artificial intelligence algorithms for the classification of prostate cancer lesions on medical images.

    Time frame: 2 years

    PET images from enrolled patients will be used to create models that investigate the ability of artificial intelligence to automate tumor segmentation tasks.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

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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