A Phase 2 interventional study of Feraheme and Magnetic Resonance Imaging (MRI) scan in Bone Cancer, Chondrosarcoma and Ewing's Sarcoma, sponsored by Heike E Daldrup-Link. Completed at 1 site in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Heike E Daldrup-Link · Phase 2, Interventional, and Diagnostic
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.
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:
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's enrollment of 32 is below the median of 44 across 163 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →This is the only study on the registry with Heike E Daldrup-Link as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous injection of Feraheme, 5 mg Fe/kg
Drug: Feraheme · Procedure: Magnetic Resonance Imaging (MRI) scan
5 mg/kg by intravenous (IV) administration
Also known as: ferumoxytol
Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Also known as: Magnetic Resonance (MR) scan
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.
Time frame: 24 hours
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.
Time frame: 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. .
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
| Milestone | Feraheme |
|---|---|
| Started | 21 |
| Bone sarcoma | 10 |
| Osteomyelitis | 4 |
| Lymphoma | 7 |
| Completed | 21 |
| Not completed | 0 |
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.
| milliseconds | Bone Sarcomas | Osteomyelitis |
|---|---|---|
| T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects | 7.3 ± 1.9 | 7.7 ± 1.9 |
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.
| milliseconds | Bone Sarcomas Pre-ferumoxytol & Post-ferumoxytol Contrast |
|---|---|
| Pre-treatment | 13.80 ± 2.80 |
| Post-treatment | 8.27 ± 2.12 |
Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 \* relaxation time determined by ferumoxytol-enhanced MRI. .
| milliseconds | Mean T2 * Relaxation Time for Lymphoma Participants | Mean T2 * Relaxation Time for Bone Sarcoma Participants |
|---|---|---|
| Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI | 14.83 ± 1.03 | 7.71 ± 0.60 |
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.
| Percentage of CD68-positive TAM | Mean Area Density of CD-68-positive TAM in Lymphoma | Mean Area Density of CD-68-positive TAM in Bone Sarcomas |
|---|---|---|
| Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas | 4.8 ± 1.2 | 6.1 ± 2.3 |
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.
| Percentage area of CD163-positive TAM | Mean Area Density of CD163-positive TAM in Lymphoma | Mean Area Density of CD163-positive TAM in Bone Sarcoma |
|---|---|---|
| Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas | 1.9 ± 1.5 | 9.4 ± 3.1 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Feraheme | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Event | Feraheme |
|---|---|
| Allergic reactionImmune system disorders | 1/21 |
| Age, Categorical(Participants) | Feraheme |
|---|---|
| <=18 years | 16 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Age, Continuous(Years) | Feraheme |
|---|---|
| Mean | 14.7 ± 4.0 |
| Sex: Female, Male(Participants) | Feraheme |
|---|---|
| Female | 11 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Feraheme |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Feraheme |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Feraheme |
|---|---|
| United States | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2011 to primary completion in Jul 2014, 35 months.
Results were first posted in Jun 2019, 4 years 11 months after primary completion.
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Studies of the drug tested here: Ferrosoferric Oxide