Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke

Enrolling by invitation

Phase Results N/A

Update History

27 Apr '18 phase not implemented.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head. Exclusion Criteria: 1. You cannot take part in this study unless you have evidence of having a stroke (hemorrhage in your brain). 2. You cannot take part in this study if you are not able to safely have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or think they might be pregnant. We will provide a one-time pregnancy test for anyone who is uncertain about being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.
Old
Inclusion Criteria: 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head. Exclusion Criteria: 1. You cannot take part in this study unless you have evidence of having a stroke (hemorrhage in your brain). 2. You cannot take part in this study if you are not able to safely have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or think they might be pregnant. We will provide a one-time pregnancy test for anyone who is uncertain about being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.
A location was updated in Ann Arbor.
New
The overall status was removed for University of Michigan Hospital.
29 Apr '17
Trial name was updated.
New
Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke
The Summary of Purpose was updated.
New
This study will determine if MRI imaging can be used to estimate the amount of iron in areas of the brain affected by a stroke. This may help future patients if the scan can be used to predict the amount of brain damage and therefore the effects on the patient. New research treatments are being used to reduce the amount of iron build-up in the brain. The effects of that treatment may also be estimated using new MRI techniques.
Old
To determine if MRI imaging can be used to determine the amount of iron in areas of the brain affected by a stroke, which may help in the future to see if this can predict the amount of brain damage and therefore the effects on the patient. New research treatments are being used to reduce the amount of iron build up in the brain; the effects of that treatment may also be seen using new MRI techniques.
The description was updated.
New
Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents. Iron chelate agents are compounds that bind iron to them and may show the extent of neural tissue damage. Initial results of human trials based on this hypothesis demonstrated the safety of increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate agents for hemorrhagic stroke is entering into phase II/III trials. There is no modality at this date that can quantify the iron in tissue non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury. We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.
Old
Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents on the extent of neural tissue damage. preliminary human trials based on this hypothesis demonstrate safety of escalating doses of desferroxamine in the human population. The evaluation of iron chelate agent in the context of hemorrhagic stroke is entering into phase II/III trials. There is no modality at this date that can quantify the iron in tissue non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury. We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head. Exclusion Criteria: 1. You cannot take part in this study unless you have evidence of having a stroke (hemorrhage in your brain). 2. You cannot take part in this study if you are not able to safely have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or think they might be pregnant. We will provide a one-time pregnancy test for anyone who is uncertain about being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.
Old
Inclusion Criteria: 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head. Exclusion Criteria: 1. You cannot take part in this study if you have no evidence of a previous stroke (hemorrhage). 2. You cannot take part in this study if you are not clinically able to have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or suspect you might be pregnant. We will provide a one-time pregnancy test for you, at no cost to you, if you are uncertain about the possibility of your being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.
6 Feb '16
The Summary of Purpose was updated.
New
To determine if MRI imaging can be used to determine the amount of iron in areas of the brain affected by a stroke, which may help in the future to see if this can predict the amount of brain damage and therefore the effects on the patient. New research treatments are being used to reduce the amount of iron build up in the brain; the effects of that treatment may also be seen using new MRI techniques.
Old
To determine if MRI imaging can be used to determine the amount of iron in areas of the brain affected by a stroke, which may help in the future to see if this can predict the amount of brain damage and therefore the effects on the patient. New research treatments are being used to reduce the amount of iron build up in the brain; the effects of that treatment may also be seen using new MRI techniques.
The description was updated.
New
Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents on the extent of neural tissue damage. preliminary human trials based on this hypothesis demonstrate safety of escalating doses of desferroxamine in the human population. The evaluation of iron chelate agent in the context of hemorrhagic stroke is entering into phase II/III trials. There is no modality at this date that can quantify the iron in tissue non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury. We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.
Old
Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents on the extent of neural tissue damage. preliminary human trials based on this hypothesis demonstrate safety of escalating doses of desferroxamine in the human population. The evaluation of iron chelate agent in the context of hemorrhagic stroke is entering into phase II/III trials. There is no modality till date that can quantify this tissue iron non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury. We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head. Exclusion Criteria: 1. You cannot take part in this study if you have no evidence of a previous stroke (hemorrhage). 2. You cannot take part in this study if you are not clinically able to have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or suspect you might be pregnant. We will provide a one-time pregnancy test for you, at no cost to you, if you are uncertain about the possibility of your being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.
Old
Inclusion Criteria: 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head. Exclusion Criteria: 1. You cannot take part in this study if you have no evidence of a previous stroke (hemorrhage). 2. You cannot take part in this study if you are not clinically able to have an MRI exam. 3. Women cannot take part in this study if they are pregnant. 4. Women may not participate in this study if they are attempting to become pregnant or suspect you might be pregnant. We will provide a one-time pregnancy test for you, at no cost to you, if you are uncertain about the possibility of your being pregnant. 5. You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.