In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
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|ClinicalTrials.gov Identifier: NCT03179449|
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Childhood Brain Neoplasm||Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI) Procedure: Surgery Drug: Ferumoxytol Other: Tissue Analysis||Early Phase 1|
I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.
I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.
Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Diagnostic (ferumoxytol-enhanced MRI)
All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.
Diagnostic Test: Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI
Undergo surgical resection
Other: Tissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
- Iron concentration measurements [ Time Frame: Day 1 ]Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol.
- Macrophages on histopathology [ Time Frame: Days 2-4 ]Determine the number of macrophages in tissue samples at histopathology.
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): NCT03179449
|Contact: Vyvian Ngoemail@example.com|
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Paymon Rezaii 650-743-8336 firstname.lastname@example.org|
|Principal Investigator: Michael Iv|
|Principal Investigator:||Michael Iv||Stanford University|