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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01433 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00025277 | Other Identifier | OHSU Knight Cancer Institute |
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no enrollment
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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This clinical trial evaluates the feasibility of performing oxygen-enhanced magnetic resonance imaging (MRI) to generate hypoxia maps in patients with intracranial tumors. Decreased levels of oxygen (hypoxia) is a hallmark of malignant brain tumors. Chronic hypoxia is a stimulator of blood vessel formation, which is required for tumor growth and spread. Hypoxia also limits the effectiveness of radiation and chemotherapy. MRI is an imaging technique that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The administration of inhaled oxygen allows for an increased MRI signal effect size. Oxygen-enhanced MRI may be a non-invasive method that can physiologically estimate tissue hypoxia. With a better understanding of the extent of tumor hypoxia, more effective and patient-specific therapies could be devised to halt malignant tumor growth.
PRIMARY OBJECTIVE:
I. Determine the feasibility of generating hypoxia maps from oxygen MRI.
SECONDARY OBJECTIVES:
I. Evaluate the association between oxygen MRI hypoxia maps generated using T2* and T1 MRI sequences.
II. Evaluate the association between oxygen MRI hypoxia maps and progression free survival.
OUTLINE:
Patients receive supplemental oxygen while undergoing standard of care MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (oxygen-enhanced MRI) | Experimental | Patients receive supplemental oxygen while undergoing standard of care MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generation of whole brain oxygen magnetic resonance imaging (MRI) data set | Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps. Following completion of cohort enrollment, the generation of each hypoxia map will be independently scored as a dichotomous variable; successful or non-successful. The successful generation of a hypoxia map from either a T1 or T2* approach in 85% of the cohort of patients will need to be achieved for the imaging modality to be deemed feasible for the purposes of this study. Will provide the estimated proportion of success rate for each metric along with the corresponding 95% exact confidence interval. | One hour of diagnostic imaging |
| Quantification of hypoxic tumor volume | Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps. | One hour of diagnostic imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between T1 and T2* sequence hypoxia volume | Will determine the association between oxygen MRI hypoxia maps generated using T2* and T1 MRI sequences. Assessed using Pearson's correlation coefficient. | One hour of diagnostic imaging |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding
Contraindication to supplemental oxygen administration, MRI, or intravenous gadolinium based contrast agents.
Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care)
Poor peripheral intravenous access evaluated by patient history
Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social situations which might impact the endpoint of the study or limit compliance with study requirements
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| Name | Affiliation | Role |
|---|---|---|
| Ramon Barajas | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D018011 | Chalcogens |
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| Oxygen Therapy | Procedure | Receive supplemental oxygen |
|
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Will perform Kaplan Meier analysis of progression free survival stratified by median T1 and T2* hypoxic volume to determine the association between oxygen MRI hypoxia maps and progression free survival. A Cox regression model will also be explored by treating hypoxic volume as a continuous variable. |
| Clinical follow up for up to 5 years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004602 |
| Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |