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 : Completed
First Posted : May 19, 2014
Results First Posted : August 27, 2019
Last Update Posted : September 6, 2019
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.
- 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: Magnetic Resonance Imaging (MRI)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 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|
|Actual Study Start Date :||May 15, 2014|
|Actual Primary Completion Date :||November 20, 2018|
|Actual Study Completion Date :||November 20, 2018|
Experimental: Ferumoxytol + Magnetic Resonance Imaging (MRI)
7.5mg/kg intravenous (IV) infusion
Other Name: Feraheme
Diagnostic Test: Magnetic Resonance Imaging (MRI)
3 MRIs: pre-infusion, 24 and 48 hours post-infusion
- Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes [ Time Frame: Baseline and 24 hours ]Visible nodes were quantified with manually contoured regions of interest on axial T2*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% * ((SInormal(24hrs)- SInormal(baseline))/ SInormal(baseline)).This image processing method was performed at baseline, 24-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 24 hours post injection.
- Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes [ Time Frame: Baseline to 48 hours post injection ]Visible nodes were quantified with manually contoured regions of interest on axial T2*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% * ((SInormal(48hrs)- SInormal(baseline))/ SInormal(baseline))). This image processing method was performed at baseline, 48-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 48 hours post-injection.
- Percent Change in Signal Difference Within Metastatic Nodes in Prostate, Kidney, Bladder Cancer Patients at Ultrasonography [ Time Frame: pre-infusion, 24 hours and 48 hours ]Patients will undergo ultrasound examination of imageable lymph nodes at pre-infusion, 24 hours and 48 hours. The signal changes at post-infusion ultrasound will be visually evaluated to determine if the uptake of ferumoxytol alters sonographic features.
- Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and ]Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
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
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Ismail B Turkbey, M.D.||National Cancer Institute (NCI)|