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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadopiclenol | Experimental | Gadopiclenol in dose, route of administration, and indication that is FDA-approved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopiclenol | Drug | Gadopiclenol for contrast enhanced MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded 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. | Through Study Completion (An Average of 1 Year Post-MRI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through Study Completion (An Average of 1 Year Post-MRI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Bloch, MD | Contact | 212 305 0519 | bnb2134@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Bloch, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000656634 | gadopiclenol |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |