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Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers

NCT02141490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-09-06

Study results available
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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.

Conditions

Interventions

DRUG

Ferumoxytol

7.5mg/kg intravenous (IV) infusion

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ismail B Turkbey, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-15
Primary Completion
2018-11-20
Completion
2018-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141490 on ClinicalTrials.gov