Phase 4
N=14
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
Osteonecrosis
Bottom Line
View on ClinicalTrials.gov: NCT02893293 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Signal to Noise Ratio (SNR) — 33.82; 129.56 dB — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ferumoxytol-enhanced magnetic resonance imaging (Drug); Magentic Resonance Imaging (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Signal to Noise Ratio (SNR) |
33.82; 129.56 | 0.002 sig |
| PRIMARY T2*-Relaxation Time |
9.04; 13.7 | 0.02 sig |
| PRIMARY Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant |
12 | — |
Summary
The goal of the project is to evaluate osteonecrosis before and after decompression surgery with ferumoxytol-enhanced MRI.
Eligibility Criteria
Inclusion Criteria
- Osteonecrosis
- planned decompression surgery with autologous stem cell transplant
Exclusion Criteria
- Contraindications for magnetic resonance imaging
- Hemosiderosis/hemochromatosis ( patients can still be included in the non-ferumoxytol arm)
Data sourced from ClinicalTrials.gov (NCT02893293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.