NCT00659126

Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors

Terminated Phase 2 Results posted Last updated 7 September 2023

What this trial tests

Phase 2 trial testing 3 Tesla Magnetic Resonance Imaging in Metastatic Malignant Neoplasm in the Brain in 40 participants. Terminated before completion.

Timeline

16 November 2006

Primary endpoint
31 December 2019

31 December 2020

Quick facts

Lead sponsor	OHSU Knight Cancer Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	16 November 2006
Primary completion	31 December 2019
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• 3 Tesla Magnetic Resonance Imaging
• Dynamic Contrast-Enhanced Magnetic Resonance Imaging
• Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
• Ferumoxytol (FERUMOXYTOL) — full drug profile →
• Gadolinium (GADOLINIUM) — full drug profile →
• High Field Strength Magnetic Resonance Imaging
• Susceptibility Weighted Imaging

Conditions studied

• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →
• Primary Brain Neoplasm — all drugs for Primary Brain Neoplasm →

Sponsor

OHSU Knight Cancer Institute

Who can join

18 and older, any sex, with Metastatic Malignant Neoplasm in the Brain or Primary Brain Neoplasm. 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.

CNR, in Terms of Normalized Signal Intensity Changes, for Dynamic Susceptibility Contrast (DSC) MRI Data Sets at 3T and 7T (Gadolinium and Ferumoxytol) Primary · Day 1 to day 2

A two sample t-test was used for primary descriptive comparisons since CNR was measured on different subjects at 3T and 7T. There were no repeated measures in the resulting data. Given the small sample size, a linear regression was conducted to compare CNR between 3T and 7T only adjusted for Fe dose. No other adjusted analyses were conducted. CNR was compared between 3T and 7T for both Ferumoxytol and Gadolinum. Ferumoxytol was administered using three injections and CNR was measured after each injection, thus we have three measures of CNR (Fe1CNR, Fe2CNR and Fe3CNR).

Gadolinium

Group	Value	95% CI
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors	1.34	± .923
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors	.912	± .519

Ferumoxytol 1st dose

Group	Value	95% CI
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors	1.034	± .611
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors	.669	± .644

Ferumoxytol 2nd dose

Group	Value	95% CI
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors	1.27	± .886
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors	1.08	± 1.15

Ferumoxytol 3rd dose

Group	Value	95% CI
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors	1.45	± .893
Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors	.886	± .964

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects were monitored for adverse events from day 1 of imaging session to 4 to 6 weeks after completing imaging.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors

Serious: 0/12 (0%)

Deaths: 0/15

Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors

Serious: 0/21 (0%)

Deaths: 0/25

Other adverse events (1 terms — click to expand)

Reaction	System	Gadolinium and Ferumoxytol…	Gadolinium and Ferumoxytol…
Diarrhea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT00659126 adverse events section.

Sponsor's own description

This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring tumors in patients undergoing treatment for brain tumors or other tumors that have spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. The contrast imaging agent ferumoxytol consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.

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. Pseudoprogression of glioblastoma after chemo- and radiation therapy: diagnosis by using dynamic susceptibility-weighted contrast-enhanced perfusion MR imaging with ferumoxytol versus gadoteridol and correlation with survival.
   Gahramanov S, Muldoon LL, Varallyay CG, Li X, et al · · 2013 · cited 110× · PMID 23204544 · DOI 10.1148/radiol.12111472
3. Engineering Iron Oxide Nanoparticles for Clinical Settings.
   Cortajarena AL, Ortega D, Ocampo SM, Gonzalez-García A, et al · · 2014 · cited 78× · PMID 30023013 · DOI 10.5772/58841
4. 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
5. Understanding Nanoparticle Toxicity to Direct a Safe-by-Design Approach in Cancer Nanomedicine.
   Damasco JA, Ravi S, Perez JD, Hagaman DE, et al · · 2020 · cited 46× · PMID 33147800 · DOI 10.3390/nano10112186
6. 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
7. 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
8. Cerebral blood volume mapping with ferumoxytol in dynamic susceptibility contrast perfusion MRI: Comparison to standard of care.
   Varallyay CG, Nesbit E, Horvath A, Varallyay P, et al · · 2018 · cited 9× · PMID 29314418 · DOI 10.1002/jmri.25943