Gadoxetate Sodium Enhanced MRI as a Biomarker for Aggressive Prostate Cancer

NCT03960788 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: EOVIST
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Comparison of Gadoxetate Sodium to gadolinium in effectiveness of identification of prostate cancer as measured by contrast enhancement ratios

  This single outcome will be measured by comparing the contrast enhancement ratio from pre-study images from participating subjects originally imaged with gadolinium enhanced contrast against contrast enhancement ratios from subjects receiving Gadoxetate Sodium enhanced scans. The measurements taken using the enhancement ratios will be for two areas of interest in the prostate in tumor tissue and these will be collected from pre-study, and post-study images only. A contrast enhancement ratio is a quantitative measure used to assess the degree of enhancement (brightness) between normal and abnormal tissue in imaging.

  3 weeks from consent

Secondary Outcomes (1)

• Comparison of the contrast enhancement ratio of OATP1B3 + and - samples taken from post-Gadoxetate Sodium subjects to determine if Gadoxetate Sodium to determine if it differentiates androgen resistant cancers.

  3 weeks from consent

Study Arms (1)

MRI with Gadoxetate Sodium

EXPERIMENTAL

Subjects will receive Gadoxetate Sodium during MRI.

Drug: Gadoxetate Sodium

Interventions

Gadoxetate Sodium DRUG

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

MRI with Gadoxetate Sodium

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only Males may apply due to condition under study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sadhna Verma, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicky Kurtzweil

CONTACT

5135840904; kurtzwny@ucmail.uc.edu

Melanie Gruen

CONTACT

15135848131; gruenml@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 23, 2019
• Study Start: January 2, 2018
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2021
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)