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NCT Number: NCT06774781

Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions

The goal of this observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna from September 2015 to March 2021.

The main question it aims to answer is:

- does the analysis of ADC values and radiomics values found in the RMmp images help with the detection of prostate cancer?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Caterina Gaudiano, MD

CONTACT

[email protected]

39 0512142307

About this study

The radiologist involved in this observational study will enroll the participants, collect their informed consent and radiological data.

The urologist will collect the clinical data while the Anatomo-pathologist will take care of the hystological data.

The ADC values of the suspected lesions and healthy parenchyma will be extracted from the MR exams. For the evaluation of radiometric characteristics, images will first be de-identified, the downloaded and processed by the hospital's medical physicists.

The engineers at the University of Bologna, led by medical investigators, will extract the radiomic characteristics All data will be anonymised and collected in a database shared between the collaborating operational units.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of one or more lesions classified as PI-RADSv2.1 ≥ 3 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
  • Indication for eco-guided targeted biopsy by fusion technique integrated with systematic biopsy
  • Indication for radical prostatectomy
  • Participants aged 18 at the time of examination
  • Obtaining informed consent.

Exclusion criteria

  • Impossibility of performing MRI (claustrophobic or obese participants etc.) or contraindications to the execution of MRI
  • Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)

Treatment and study plan

Primary outcomes

  1. Distribution of ADC

    Time frame: From enrollment to the end of treatment at 4 years

    Evaluate the distribution of ADC values of the prostatic lesions cataloged according to the criteria PI-RADSv2.1 ≥ 3, comparing it with the distribution of ADC values of the healthy glandular tissue, to define a predictive threshold value for clinically significant neoplastic lesion.

Study contacts

Contact information is provided by the study sponsor or research team.

Caterina Gaudiano, MD

CONTACT

[email protected]

+39 0515142307

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Assessment of the Distribution of ADC Values and Radiometric Characteristics of Suspect Areas With a Multiparametric MRI of the Prostate to Identify Clinically Significant Neoplastic Lesions

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

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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