At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Metastases in Genitourinary (Prostate, Bladder and Kidney) Cancers
In Brief
A Phase 2 clinical trial evaluating Ferumoxytol and Magnetic Resonance Imaging (MRI) for Prostate Cancer and 2 related conditions. Completed, enrolled 43 participants across 1 site.
Detailed Summary
Background: People with prostate, bladder, or kidney cancer often have their cancer spread (metastasize) to lymph nodes. It is important for your doctor to know if this has occurred but currently it can be hard to determine if this has occurred on standard imaging studies like computed tomography (CT) or magnetic resonance imaging (MRI). This study uses an agent called Ferumoxytol to identify lymph nodes that might be involved by cancer. Objective: \- To see how well Ferumoxytol can detect lymph node metastases in patients with prostate, bladder, or kidney cancer. Eligibility: -Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement. Design: * Participants will be screened with a medical history. * Participants will have blood drawn and a physical exam. Their vital signs will be measured. They will answer questions about their health and current medications. * Participants should not have a history of iron overload or have an allergy to Ferumoxytol. * Participants will have a magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder with a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. They will have a standard sensor, known as a coil, wrapped around their abdomen to improve the scan. This is like a small blanket with wiring inside. Participants will need to lie still on the scanning table for about 1 hour. * Participants will have an ultrasound. This uses harmless sound waves to provide pictures of organs or tissues inside the body. * Participants will receive an injection of Ferumoxytol through an intravenous line. A very thin plastic tube will be inserted into a vein in order to inject the agent. * Participants will have another MRI and ultrasound 24 and 48 hours after injection. * The study will follow participants medical course for at least 1 year.
Study Details
Timeline
Interventions
7.5mg/kg intravenous (IV) infusion
3 MRIs: pre-infusion, 24 and 48 hours post-infusion