TriangleNCT00103038 · OUTCOME
Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Values on a scale
- Interval / dispersion
- Full Range
- Time frame
- Summarized after completion of up to 6 imaging sessions (up to 5 years)
What was measured
Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity).
Groups in this outcome
Malignant Brain Tumor Patients Undergoing Brain MRI
Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA
| Group | Source count |
|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI | 12 |
Reported measurements
Peritumor area gadolinium rCBV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI | 146 | Not reported | 0 | 180 | Not reported |
Peritumor area ferumoxytol rCBV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI | 136 | Not reported | 0 | 180 | Not reported |
Tumor area gadolinium rCBV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI | 39 | Not reported | 0 | 180 | Not reported |
Tumor area ferumoxytol rCBV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI | 54 | Not reported | 0 | 180 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 180
- value
- 146
- title
- Peritumor area gadolinium rCBV
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 180
- value
- 136
- title
- Peritumor area ferumoxytol rCBV
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 180
- value
- 39
- title
- Tumor area gadolinium rCBV
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 180
- value
- 54
- title
- Tumor area ferumoxytol rCBV
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity).
- dispersion Type
- Full Range
- groups
- description
- Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA
- id
- OG000
- title
- Malignant Brain Tumor Patients Undergoing Brain MRI
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Summarized after completion of up to 6 imaging sessions (up to 5 years)
- title
- Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps.
- type
- PRIMARY
- unit Of Measure
- Values on a scale
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