Recruiting
Early Phase 1

Gadoxetate Sodium

Sponsor:

University of Cincinnati

Code:

NCT03960788

Conditions

Cancer of the Prostate

Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gadoxetate Sodium

Study Details

Brief summary:

The purpose of this research study is to test to see if Gadoxetate Sodium is a useful contrast agent for detecting prostate cancer during magnetic resonance imaging (MRI). Gadoxetate Sodium is an FDA approved contrast agent that is currently used to detect liver cancer. Gadoxetate Sodium shows promise in identifying more aggressive prostate cancers at earlier stages. The study will also test to see if specific genes are expressed in the left over tissue samples from previous prostate fusion biopsy. The investigators hypothesize that Gadoxetate Sodium-enhanced MRI can differentiate aggressive prostate cancer and predict its early recurrence.

Conditions

Cancer of the Prostate

Castration-resistant Prostate Cancer

Study ID

NCT03960788

Start date

Jan 2, 2018

Status verified date

May, 2019

Completion date

Jan 2, 2021

Anticipated

Primary completion date

Jan 2, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject is greater than or equal to 18 years old.
  • Subjects with clinically localized OR advanced prostate cancer with biopsy confirmation and sufficient tissue available (obtained before Gadoxetate Sodium injection) for OATP1B3 expression.
  • Subjects must have a prior MRI with gadolinium obtained as part of their standard of care for comparison available. This may have been obtained as part of an image guided biopsy.
  • Serum creatinine within 3 weeks prior to Gadoxetate Sodium MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 60 ml/min/1.73m.
  • Patients must have normal liver function as defined below: total bilirubin less than 2 times normal institutional limits or greater than 3.0 mg/dl in patients with Gilbert s syndrome AST(SGOT) and ALT(SGPT) less than or equal to 3 times institutional upper limit of normal
  • Ability of subject to sign a written informed consent document.

Exclusion Criteria:

  • Subjects that have received a prostatectomy
  • Subjects with known hypersensitivity and allergy to gadolinium contrast agents
  • Subjects with chronic kidney disease or acute kidney injury. Chronic Kidney disease is GFR<30. Acute kidney injury (AKI) is defined as an abrupt or rapid decline in renal filtration function and is screened by excluding patient's that have a GFR <60 within 3 weeks of their scan, as well as screening patients on the day of the scan for kidney disease and contraindications using the standard form based on the Updated ACR Screening Recommendations on Gadolinium Based MR Contrast Agents, Renal Disease Patients. Patients who show signs of renal disease from this form will be excluded from the study.
  • Subjects with contraindications to MRI
  • Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MRI with Gadoxetate Sodium

Subjects will receive Gadoxetate Sodium during MRI.

Interventions

Gadoxetate Sodium

Gadoxetate Sodium is an FDA approved contrast agent to be used during magnetic resonance imaging.

Primary outcome measure

  • Comparison of Gadoxetate Sodium to gadolinium in effectiveness of identification of prostate cancer as measured by contrast enhancement ratios [ Time Frame: 3 weeks from consent ]

Central Contacts and Locations

Central contacts

Nicky Kurtzweil

5135840904kurtzwny@ucmail.uc.edu

Melanie Gruen

15135848131gruenml@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Benjamin Quast

513-584-0220quastbn@ucmail.uc.edu

Principal Investigator:

Sadhna Verma, MD

More Information

Sponsor

University of Cincinnati

Last update posted

May 23, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2019-05-23.