TriangleNCT00103038 · OUTCOME
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Summarized after completion of up to 6 imaging sessions (up to 5 years)
What was measured
We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \\ \[A ∩ B ∩ C\]). Higher values in signal intensity indicated increased image enhancement.
Analysis population: 58 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome.
Groups in this outcome
Malignant Brain Tumor Patients Undergoing Brain MRI- Gadolinium-enhanced 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
Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced 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- Gadolinium-enhanced MRI | 58 |
| Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI | 58 |
| Group | Source count |
|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI- Gadolinium-enhanced MRI | 193 |
| Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI | 193 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Brain Tumor Patients Undergoing Brain MRI- Gadolinium-enhanced MRI | 1.36 | 0.107 | Not reported | Not reported | Not reported |
| Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI | 1.26 | 0.108 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.107
- value
- 1.36
- group Id
- OG001
- spread
- 0.108
- value
- 1.26
- denom Units Selected
- Images
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 58
- units
- Participants
- counts
- group Id
- OG000
- value
- 193
- group Id
- OG001
- value
- 193
- units
- Images
- description
- We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \\ \[A ∩ B ∩ C\]). Higher values in signal intensity indicated increased image enhancement.
- dispersion Type
- Standard Deviation
- 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- Gadolinium-enhanced MRI
- 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
- OG001
- title
- Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI
- param Type
- MEAN
- population Description
- 58 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome.
- reporting Status
- POSTED
- time Frame
- Summarized after completion of up to 6 imaging sessions (up to 5 years)
- title
- Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity)
- type
- SECONDARY
- type Units Analyzed
- Images
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice