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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03960788
Other study ID # EOVIST
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 2, 2018
Est. completion date January 2, 2021

Study information

Verified date May 2019
Source University of Cincinnati
Contact Nicky Kurtzweil
Phone 5135840904
Email kurtzwny@ucmail.uc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. This single outcome will be measured by collecting a tumor tissue biopsy post scan with Gadoxetate Sodium, performing a molecular analysis for the genetic marker OATP1B3 (agent present in resistant cancers) and comparing the contrast enhancement ratio in those samples that have OATP1B3 to those samples without.
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
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