CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Eovistdrug
Likely dose
Eovist 0.1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01867424
NCT01867424Phase 2Completed

Pilot Study of Eovist (Gadoxetate) Enhanced MRI for the Detection of Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Jun 4, 2013·Updated Jul 8, 2020

In Brief

A Phase 2 clinical trial evaluating Eovist for Prostate Cancer. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Background: \- Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well. Objectives: \- To see if gadoxetate can help identify different types of prostate cancers during imaging studies. Eligibility: \- Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. * Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan. * Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study. * Treatment will not be provided as part of this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2013
Enrollment StartMay 14, 2013
Primary CompletionMay 30, 2016
Study CompletionDec 8, 2016
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.1 years ago

Interventions

Eovistdrug

0.1 ml/kg Eovist will be administered intravenous (IV) to each patient