CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Ferumoxytoldrug
Likely dose
Ferumoxytol 7.5mg/kgfrom 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/NCT01296139
NCT01296139Phase 1Completed

Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Feb 15, 2011·Updated Jul 5, 2018

In Brief

A Phase 1 clinical trial evaluating Ferumoxytol for Prostate Cancer. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Background: \- Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for use as an imaging agent, researchers are interested in testing its effectiveness as a contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of individuals with prostate cancer. Objectives: \- To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer. Eligibility: \- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have surgery to remove the prostate and surrounding lymph nodes. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. * Participants will have a magnetic resonance imaging (MRI) scan to provide baseline images for the study. * Participants will receive an injection of Ferumoxytol and will return for another MRI scan on the following day (around 24 hours later). * Some participants may have a third MRI scan 48 hours after the initial injection of Ferumoxytol. This third MRI scan is optional and not required by the study. * Although the scanning and followup portion of the study will last only a few days, participants will be considered to be enrolled on the study until after the prostate removal surgery.

Study Details

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

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2011
Enrollment StartJan 26, 2011
Primary CompletionMar 19, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.4 years ago

Interventions

Ferumoxytoldrug

All subjects will undergo pre-injection, 24, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) MRI consisting of T1 weighted (W), T2W and T2\*W MRI in a 3 Tesla magnet. Additionally, all subjects will undergo pre-injection, 24 hours, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) ultrasound.