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NCT00103038

Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases

Completed NA Results posted Last updated 9 June 2022
What this trial tests

NA trial testing 3 Tesla Magnetic Resonance Imaging in Central Nervous System Lymphoma in 155 participants. Completed in 10 June 2016.

Timeline
4 June 2004
Primary endpoint
10 May 2016
10 June 2016

Quick facts

Lead sponsorOHSU Knight Cancer Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment155
Start date4 June 2004
Primary completion10 May 2016
Estimated completion10 June 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

OHSU Knight Cancer Institute

Who can join

18 and older, any sex, with Central Nervous System Lymphoma or Malignant Glioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps. Primary · Summarized after completion of up to 6 imaging sessions (up to 5 years)

Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) we

Peritumor area gadolinium rCBV
GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI1460 – 180
Peritumor area ferumoxytol rCBV
GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI1360 – 180
Tumor area gadolinium rCBV
GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI390 – 180
Tumor area ferumoxytol rCBV
GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI540 – 180
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume) Secondary · Summarized after completion of up to 6 imaging sessions (up to 5 years)

We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Enhancement volumes normalized to normal appearing white matter were calculated with histogram analysis. Enhancement cube root volumes were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant.

GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI- Gadolinium-enhanced MRI21.71± 6.396
Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI18.71± 6.884
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity) Secondary · Summarized after completion of up to 6 imaging sessions (up to 5 years)

We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \\ \[A ∩ B ∩ C\]). Higher values in signal intensity

GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI- Gadolinium-enhanced MRI1.36± 0.107
Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI1.26± 0.108
Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI Secondary · Assessed after each visit for up to 6 imaging sessions (up to 5 years)

We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs.

Median survival in patients with pseudoprogression seen on Fe-MRI
GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI34.720.3 – 54.1
Median survival in patients with real progression seen on Fe-MRI
GroupValue95% CI
Malignant Brain Tumor Patients Undergoing Brain MRI13.411.1 – 19.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects were evaluated for adverse events approximately 4-6 weeks after each study visit, up to 5 years.. Reporting threshold: 0.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)
Serious: 0/152 (0%)
Deaths: 119/155
Other adverse events (1 terms — click to expand)

ReactionSystemMalignant Brain Tumor Pati…
HypertensionCardiac disorders

Data from ClinicalTrials.gov NCT00103038 adverse events section.

Sponsor's own description

This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Review of Clinical Translation of Inorganic Nanoparticles.
    Anselmo AC, Mitragotri S. · · 2015 · cited 263× · PMID 25956384 · DOI 10.1208/s12248-015-9780-2
  2. Clinical Trials of Thermosensitive Nanomaterials: An Overview.
    Nardecchia S, Sánchez-Moreno P, Sánchez-Moreno P, Vicente J, et al · · 2019 · cited 60× · PMID 30717386 · DOI 10.3390/nano9020191
  3. Imaging vascular and hemodynamic features of the brain using dynamic susceptibility contrast and dynamic contrast enhanced MRI.
    Quarles CC, Bell LC, Stokes AM. · · 2019 · cited 50× · PMID 29729392 · DOI 10.1016/j.neuroimage.2018.04.069
  4. Nanotherapeutic treatment of the invasive glioblastoma tumor microenvironment.
    Pandey N, Anastasiadis P, Carney CP, Kanvinde PP, et al · · 2022 · cited 43× · PMID 35787387 · DOI 10.1016/j.addr.2022.114415
  5. Surface-engineered multimodal magnetic nanoparticles to manage CNS diseases.
    Tomitaka A, Kaushik A, Kevadiya BD, Mukadam I, et al · · 2019 · cited 39× · PMID 30660756 · DOI 10.1016/j.drudis.2019.01.006
  6. MRI and PET of Brain Tumor Neuroinflammation in the Era of Immunotherapy, From the <i>AJR</i> Special Series on Inflammation.
    Kersch CN, Ambady P, Hamilton BE, Barajas RF. · · 2022 · cited 16× · PMID 34259035 · DOI 10.2214/ajr.21.26159
  7. Distinguishing Extravascular from Intravascular Ferumoxytol Pools within the Brain: Proof of Concept in Patients with Treated Glioblastoma.
    Barajas RF, Schwartz D, McConnell HL, Kersch CN, et al · · 2020 · cited 13× · PMID 32527840 · DOI 10.3174/ajnr.a6600
  8. Quantitative comparison of delayed ferumoxytol T<sub>1</sub> enhancement with immediate gadoteridol enhancement in high grade gliomas.
    Horváth A, Varallyay CG, Schwartz D, Toth GB, et al · · 2018 · cited 6× · PMID 29205477 · DOI 10.1002/mrm.27028

Verify or expand the search:

Other trials of 3 Tesla Magnetic Resonance Imaging

Trials testing the same drug.

Other recruiting trials for Central Nervous System Lymphoma

Currently open trials in the same condition.

Other OHSU Knight Cancer Institute trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00103038.

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