MR Radiomic Features in Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT04219059
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

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 Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of surrogate bioimaging markers of histological characteristics in MR images	0-2 years	Segment tumor volumes on the ADC map and extract different imaging features

Secondary Outcome Measures

Name	Time	Method
Radiomic features from MRI	0-2 years	Evaluate if radiomic features on primitive prostate lesions can describe lymph node involvement.
Extract radiomic features	0-2 years	Evaluate if radiomic features fro MRIon primitive prostate lesions can describe disease extension.

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy