Bone CancerPhase 2OsteosarcomaNCT01336803
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
A Phase 2 study testing Feraheme and Magnetic Resonance Imaging (MRI) scan in people with Bone Cancer and Chondrosarcoma, run by Heike E Daldrup-Link at 1 site in United States.
Trial summary
This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result… Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Bone Cancer, Chondrosarcoma, Ewing's Sarcoma
- What is being tested?
- Feraheme and Magnetic Resonance Imaging (MRI) scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10 to 21 years
- Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
- Informed consent with assent as appropriate.
Who cannot join
- Contraindication to MRI
- Presence of metal implants
- Need for sedation or anesthesia
- Claustrophobia
- Hemosiderosis or hemochromatosis
- History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study
- Females who are pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.
Read the detailed description
BACKGROUND; In this study, T1, T2, and T2* represent parameters of magnetic resonance imaging (MRI).
The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).
T2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 * is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2*). T2* is always ≤ T2. In this study, T2 * is assessed after 24 hours.
OUTLINE:
Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.
PRIMARY OBJECTIVES:
- Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast T1-weighted images.
- Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.
- Establish T2-weighted MR imaging characteristics of iron-labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.
- Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam. These patients will server as controls.
- Conditions
- Bone Cancer, Chondrosarcoma, Ewing's Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Bone Necrosis
- Being tested
- Feraheme, Magnetic Resonance Imaging (MRI) scan
- Medical subject headings
- Bone Neoplasms, Chondrosarcoma, Sarcoma, Ewing, Osteosarcoma, Rhabdomyosarcoma, Osteonecrosis, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerahemeDrug
Also called ferumoxytol
5 mg/kg by intravenous (IV) administration
Magnetic Resonance Imaging (MRI) scanProcedure or surgery
Also called Magnetic Resonance (MR) scan
Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
| Study group | Role | What they receive |
|---|---|---|
| Feraheme | Experimental | Intravenous injection of Feraheme, 5 mg Fe/kg Receives: Drug: Feraheme; Procedure: Magnetic Resonance Imaging (MRI) scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects
Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 * relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 * values, with standard deviation.
Measured: 24 hours
Secondary outcomes (4)
Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast
Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 * relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only.
Measured: Baseline and Post-Treatment-24 hours
Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI
Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI.
.
Measured: 24 hours
Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations.
Measured: 24 hours
Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heike E Daldrup-Link
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heike E Daldrup-Link, Stanford University
- Investigators
- Heike E Daldrup-Link, MD, Principal investigator, Stanford UniversityNeyssa Marina, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336803
- Sponsor's protocol ID
- IRB-20253(osteosarcoma)
- Other IDs
- SU-04062011-7666, PEDSBONE0006
- Acronym
- Osteosarcoma
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2011
- Last updated
- 27 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
- ClinicalTrials.gov ID
- NCT01336803
- Acronym / sponsor ID
- Osteosarcoma / IRB-20253(osteosarcoma)
- Conditions
- Bone Cancer, Chondrosarcoma, Ewing's Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Bone Necrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Heike E Daldrup-LinkUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.
Detailed description
BACKGROUND; In this study, T1, T2, and T2* represent parameters of magnetic resonance imaging (MRI).
The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).
T2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 * is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2*). T2* is always ≤ T2. In this study, T2 * is assessed after 24 hours.
OUTLINE:
Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.
PRIMARY OBJECTIVES:
- Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast T1-weighted images.
- Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.
- Establish T2-weighted MR imaging characteristics of iron-labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.
- Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam. These patients will server as controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feraheme | Experimental | Drug: Feraheme, Procedure: Magnetic Resonance Imaging (MRI) scanIntravenous injection of Feraheme, 5 mg Fe/kg |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 10 to 21 years
- Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
- Informed consent with assent as appropriate.
Key exclusion criteria (7 listed)
- Contraindication to MRI
- Presence of metal implants
- Need for sedation or anesthesia
- Claustrophobia
- Hemosiderosis or hemochromatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerahemeAlso: ferumoxytol5 mg/kg by intravenous (IV) administration | Drug | Feraheme |
| Magnetic Resonance Imaging (MRI) scanAlso: Magnetic Resonance (MR) scanStandard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/ | Procedure or surgery | Feraheme |
Primary outcome
T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects
Time frame: 24 hours
Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 * relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 * values, with standard deviation.
4 secondary outcomes
Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast
Time frame: Baseline and Post-Treatment-24 hours
Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI
Time frame: 24 hours
Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
Time frame: 24 hours
Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike E Daldrup-Link, MD principal investigator
Stanford University
Neyssa Marina, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Feraheme and Magnetic Resonance Imaging (MRI) scan in people with Bone Cancer and Chondrosarcoma, run by Heike E Daldrup-Link at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.