Gadopiclenol in Contrast Enhanced MRI of the Prostate

U

University of Massachusetts, Worcester

Status and phase

Not yet enrolling
Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Gadopiclenol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06226129
STUDY00000969

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Gadopiclenol
Experimental group
Description:
Gadopiclenol in dose, route of administration, and indication that is FDA-approved.
Treatment:
Drug: Gadopiclenol

Trial contacts and locations

1

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Central trial contact

Sara Schiller, MPH

Data sourced from clinicaltrials.gov

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