Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers
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|ClinicalTrials.gov Identifier: NCT02141490|
Recruitment Status : Recruiting
First Posted : May 19, 2014
Last Update Posted : February 5, 2018
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 CT or MRI. This study uses an agent called Ferumoxytol to identify lymph nodes that might be involved by cancer.
- To see how well Ferumoxytol can detect lymph node metastases in patients with prostate, bladder, or kidney cancer.
-Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Bladder Cancer Kidney Cancer||Drug: Ferumoxytol Diagnostic Test: MRI||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Metastases in Genitourinary (Prostate, Bladder and Kidney)Cancers|
|Study Start Date :||May 15, 2014|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
U.S. FDA Resources
7.5mg/kg IV infusionDiagnostic Test: MRI
3 MRIs: pre-infusion, 24 and 48 hours post-infusion
- Compare the difference in signal between metastatic and normal nodes [ Time Frame: 1 year ]Signal difference in metastatic and normal nodes
- To determine the most optimal timing for imaging: 24 hours vs. 48hours post injection [ Time Frame: 1 year ]Timing for imaging: 24 hours vs. 48 hours post infusion
- To determine the difference in signal within metastatic nodes in prostate, kidney, bladder cancer patients at ultrasonography [ Time Frame: 1 year ]Signal difference in metastatic and normal nodes at ultrasonography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141490
|Contact: Yolanda McKinney, R.N.||(301) firstname.lastname@example.org|
|Contact: Ismail B Turkbey, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Ismail B Turkbey, M.D.||National Cancer Institute (NCI)|