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Contrast Agent
Ferumoxytol-enhanced MRI for Osteonecrosis (Osteonecro Trial)
Phase 4
Waitlist Available
Led By Heike Daldrup-Link, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Osteonecro Trial Summary
This trial is studying how well ferumoxytol-enhanced MRI works in diagnosing osteonecrosis before and after decompression surgery.
Osteonecro Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of treatment response to decompression surgery and stem cell transplant
Osteonecro Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Ferumoxytol-enhanced MRIActive Control2 Interventions
Patients receive a ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration) prior to routine decompression surgery and autologous stem cell transplant. Follow-up imaging with magnetic resonance imaging will be conducted in regular intervals for evaluation of the response to treatment.
Group II: Non-ferumoxytol enhanced MRIPlacebo Group1 Intervention
Patients scheduled for routine decompression surgery and autologous stem cell transplant will receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,988 Total Patients Enrolled
1 Trials studying Osteonecrosis
192 Patients Enrolled for Osteonecrosis
Heike Daldrup-Link, MD, PhDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Ferumoxytol-enhanced MRI
- Group 2: Non-ferumoxytol enhanced MRI
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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