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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01479 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00016043 | Other Identifier | OHSU Knight Cancer Institute | |
| K08CA237809 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
| Weill Cornell University | UNKNOWN |
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This phase II trial studies how well ¹⁸F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. FMISO provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET/MRI imaging produces images of the brain and how the body functions. FMISO PET/MRI may help investigators see how much oxygen is getting in the brain tumors.
PRIMARY OBJECTIVES:
I. Determine the feasibility of obtaining ¹⁸F- fluoromisonidazole (FMISO) PET (hypoxic volume and tumor to blood background values [T/B]) and dynamic susceptibility contrast enhanced (DSC) & diffusion-weighted imaging (DWI) MRI measures in patients with intracranial brain tumors.
II. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial.
SECONDARY OBJECTIVE:
I. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging co-registration.
TERTIARY OBJECTIVE:
I. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments.
OUTLINE:
Participants receive FMISO intravenously (IV). Participants also undergo dynamic PET/computed tomography (CT) or PET/MRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET/CT or PET/MRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants then undergo a retest examination within 7 days. Participants may undergo 2 more PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal.
After conclusion of the diagnostic tests, participants are followed for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (FMISO, PET/MRI or PET/CT) | Experimental | Participants receive FMISO intravenously (IV). Participants also undergo dynamic PET/computed tomography (CT) or PET/MRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET/CT or PET/MRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants then undergo a retest examination within 7 days. Participants may undergo 2 more PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ¹⁸F-Fluoromisonidazole | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Macro-imaging level feasibility | Assessed as a factor of generating quantitative positron emission tomography (PET)/magnetic resonance imaging (MRI) metrics (intra-tumoral FMISO tumor to blood [T/B] level, hypoxic volume, dynamic susceptibility contrast enhanced [DSC], and diffusion-weighted imaging [DWI] values, and tissue oxygen maps). Images generated during the administration of oxygen will be used to generate tissue oxygen maps of the brain. Following completion of cohort enrollment, the generation of each quantitative PET/MRI metric will be independently scored as a dichotomous variable; successful or non-successful. Proportional assessment will be performed to assess for project feasibility. The successful generation of PET/MRI metrics in 85% of the initial cohort successfully imaged will need to be achieved for the imaging modality to be deemed feasible for this study. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided. | One day of diagnostic imaging |
| MRI contrast enhancement | Measured by Response assessment in neuro-oncology criteria sum product diameter assessment. The primary outcomes for this aim are enhancement mismatch ratio and hypoxic volume. Differences in imaging metrics will be evaluated using two sample t-test. If normal assumption is not satisfied, data transformation, or 95% confidence intervals based on bootstrapping method will be used. Exploratory analysis will assess diagnostic performance of imaging metrics (mismatch ratio and hypoxic volume) to identify pseudoprogression at earlier imaging dates. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Technical feasibility of PET/MRI | The generation of co-registered imaging data sets will be independently scored as a dichotomous variable; successful or non-successful (< 10mm versus [vs.] > 10mm alignment error). Proportional assessment will be performed to assess for project feasibility. The estimated proportion along with the corresponding 95% binomial confidence interval will be provided. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breast feeding.
Contraindication to PET, MRI, FMISO, 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 | Recruiting | 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 |
|---|---|
| C031843 | fluoromisonidazole |
| D009682 | Magnetic Resonance Spectroscopy |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D018011 | Chalcogens |
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| Computed Tomography | Procedure | Undergo PET/CT |
|
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| Magnetic Resonance Imaging | Procedure | Undergo PET/MRI or PET/CT |
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| Positron Emission Tomography | Procedure | Undergo PET/MRI |
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| Oxygen Therapy | Procedure | Receive supplemental oxygen |
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| Baseline to the start of long-term follow-up (up to 5 years) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004602 |
| Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |