Gadopiclenol in Contrast Enhanced MRI of the Prostate

Prostate Cancer Clinical Trial

Official title:

Gadopiclenol (Elucirem): A New Gadolinium Based Contrast Agent With High Relaxivity for Increased Contrast and Improved Differentiation of Clinically Significant Prostate Cancer on Contrast Enhanced MRI: A Prospective Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226129
• Other study ID #: STUDY00000969
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: January 2024
• Source: University of Massachusetts, Worcester
• Contact: Sara Schiller, MPH
• Phone: 774-525-1517
• Email: sara.schiller1[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo a clinically indicated MRI of the prostate with contrast.

• Scheduled to undergo, or likely to be scheduled to undergo, a prostate MRI-US fusion biopsy with histology results available within 6 months of their MRI.

Exclusion Criteria:

• Prisoner

• Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.

• Patients with end stage renal failure who are on dialysis. Patients who have chronic kidney disease or acute kidney injury are contraindicated for MRI per FDA and ACR (American College of Radiologists) guidelines and would thus be excluded as well.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Gadopiclenol
Gadopiclenol for contrast enhanced MRI

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)