The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories.
Gadolinium based contrast agents with higher relaxivity have been shown to improve contrast enhancement and differentiation of tissues with increased blood perfusion or with higher microvascular density (MVD), and therefore increase visibility of cancerous tissue. In this study, the objective is to demonstrate that Gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, compared to T2-W (T2 weighted image) and diffusion weighted imaging (DWI), using the detailed location-specific (individual biopsy core for each annotated target) results of subsequently performed MRI-US fusion biopsies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Gadopiclenol for contrast enhanced MRI
Columbia University Medical Center
New York, New York, United States
RECRUITINGBlinded Radiology Review of Enhancement of Images, Graded 1-5
Single qualitative grade for contrast enhancement quality, with each exam being graded on a scale of 1-(Fail) to 5-(Excellent) contrast enhancement quality.
Time frame: Through Study Completion (An Average of 1 Year Post-MRI)
Quantitative Measurements of Wash-In/Wash-Out Contrast Curve
The secondary outcomes will be the quantitative measurement of the wash-in/wash-out contrast curve of the individual PI-RADS lesions.
Time frame: Through Study Completion (An Average of 1 Year Post-MRI)
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