Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ferumoxytol · 1 trial · 3 indications
Primary analysis will use the average score of the two readers. The mean difference and the associated 95% confidence interval (CI) between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).
Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).
Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).
Will assess the confidence in identifying the lesion corresponding areas on CBV maps as well as signal change (deltaR2\*) and relative cerebral blood volume. Primary analysis will use the average score of the two readers. The mean difference and the associated 95% CI between the two groups will be estimated using a linear regression model. Equivalence will be claimed if the 95% CI does not include 0.4 on either side (equivalence margin is 0.4).
| Arm | Type | Description |
|---|---|---|
| Group I (gadolinium, ferumoxytol, MRI) | EXPERIMENTAL | Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1. |
| Group II (ferumoxytol, gadolinium, MRI) | EXPERIMENTAL | Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1. |
| Name | Type | Description |
|---|---|---|
| Ferumoxytol | DRUG | Given IV |
| Gadolinium | DRUG | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
Inclusion Criteria: * Subjects must have one of the following: * Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.) * Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature) * Neoplastic process elsewhere in the ...