MR Radiomic Features in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

MR Radiomic Features in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219059
• Other study ID #: ProTex
• Status: Completed
• Start date: September 3, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milano

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	IBFM-CNR (Istituto di Bioimmagini e Fisiologia Molecolare, National Research Council, Segrate, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of surrogate bioimaging markers of histological characteristics in MR images	Segment tumor volumes on the ADC map and extract different imaging features	0-2 years
Secondary	Radiomic features from MRI	Evaluate if radiomic features on primitive prostate lesions can describe lymph node involvement.	0-2 years
Secondary	Extract radiomic features	Evaluate if radiomic features fro MRIon primitive prostate lesions can describe disease extension.	0-2 years