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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.
This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Imaging and Biopsy | Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FET F-18 | Drug | PET scan with FET prior to biopsy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Classification sensitivity | Statistical evaluation of the area under the ROC curve. 3.1.1 SMM classification sensitivity to >80% 3.1.2 Reduce computation time by a factor of 10, and maintain accuracy (>.95) | Through study completion, an average of 1 year. |
| Multivariate analysis | Statistically determine if MRI, and 15O-H2O and FET-PET (if available) independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences | 2032 |
| Survival | Statistically determine if SMM classifications using MRI, and 15O-H2O and FET-PET (if available) can predict progression-free survival (PFS) and overall survival (OS), and individual voxel responses to chemotherapy and radiation therapy. | 2032 |
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Inclusion Criteria
Exclusion Criteria
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Our subject population will consist of a single-arm of human glioma patients (WHO grade II-IV) in an age range of 18-89 years. Patients will be recruited from the IU Health system of academic hospitals including Simon Cancer Center (an NCI-designated Comprehensive Cancer Center), Methodist Hospital, University Hospital, Neuroscience Center, North Hospital, and Saxony Hospital. The total recruitment target for this protocol is up to 20 glioma patients, or approximately 10 patients per year.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Parker, PhD | Contact | (317) 274-2072 | parkerjg@iu.edu | |
| Jason Parker, PhD | Contact | 317-274-2072 | parkerjg@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Parker, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C545932 | (18F)fluoroethyltyrosine |
| C000615263 | Oxygen-15 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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Small (~30mg) tumor tissue samples are removed from the tumor bed and microenvironment using stereotactic core biopsy immediately before performing tumor resection.
| O-15 Radioisotope |
| Drug |
PET scan with O-15 Water prior to biopsy |
|
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| CT scan | Procedure | CT scan prior to biopsy |
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| MRI with gadolinium-based contrast | Procedure | MRI prior to biopsy |
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| Biopsy Collection | Procedure | Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |