MR Radiomic Features in Prostate Cancer

January 24, 2023 updated by: Francesco De Cobelli, IRCCS San Raffaele
A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Study Overview

Status

Completed

Conditions

Detailed Description

Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, "radiomics", is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20153
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

200 male patients who have a pre-intervention prostate MRI with contrast agent from December 2015 to August 30, 2019 and biopsy proven Pca diagnosis, followed by radical prostatectomy will be evaluated.

Description

Inclusion Criteria:

  • > 18 years of age
  • In house MRI with contrast medium
  • PCa (prostate cancer) biopsy proven diagnosis
  • In house radical prostatectomy

Exclusion Criteria:

  • < 18 years of age
  • MRI without contrast medium
  • Radical prostatectomy executed not in Institution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of surrogate bioimaging markers of histological characteristics in MR images
Time Frame: 0-2 years
Segment tumor volumes on the ADC map and extract different imaging features
0-2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiomic features from MRI
Time Frame: 0-2 years
Evaluate if radiomic features on primitive prostate lesions can describe lymph node involvement.
0-2 years
Extract radiomic features
Time Frame: 0-2 years
Evaluate if radiomic features fro MRIon primitive prostate lesions can describe disease extension.
0-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

IBFM-CNR (Istituto di Bioimmagini e Fisiologia Molecolare, National Research Council, Segrate, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProTex

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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