Registering Genomics and Imaging of Tumors (ReGIT)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Drug: FET F-18
PET scan with FET prior to biopsy
Drug: O-15 Radioisotope
PET scan with O-15 Water prior to biopsy
Other Names:
Procedure: CT scan
CT scan prior to biopsy
Procedure: MRI with gadolinium-based contrast
MRI prior to biopsy
Procedure: Biopsy Collection
Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision
|
Outcome Measures
Primary Outcome Measures
- Sensitivity of mathematical algorithms for identifying the presence of genomic mutations from the in vivo images alone. [Through study completion, an average of 1 year.]
This will include new classifiers based on regularized logistic regression and hybrid convolutional/recurrent neural networks combined with a nonparametric permutation inference FWER correction framework.
Secondary Outcome Measures
- A list of which scans are necessary for statistically valid routine clinical classification of genomic abnormalities. [Through study completion, an average of 1 year.]
This will require statistically determining if 15O-H2O-PET, FET-PET, or MRI sequences independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences.
- Accuracy of the mathematical algorithms to predict progression-free survival (PFS) and overall survival (OS). [Through study completion, an average of 1 year.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is between 18 and 89 years of age.
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Subject has radiologically-diagnosed WHO Grade II-IV glioma.
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Subject is treatment-naïve for the above condition.
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Subject is planning to undergo surgical resection and biopsy of their brain tumor.
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Subject has sufficient tissue so that the study team is able to acquire at least 2 samples during resection.
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Subject is able to read and write in English.
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Subject is able to lay supine for up to 80 minutes.
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Subject is able to hold still during MRI procedures.
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Subject has signed the consent form for participation in the study.
4.2 Exclusion Criteria
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Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy,
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Subject has serious unstable medical or mental illness.
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Subject has insufficient tissue to acquire at least two biopsy samples during resection.
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Subject has a medical contraindication to any element of the study procedures.
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Subject has not read and signed the informed consent form, or does not understand its contents.
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Subject is pregnant.*
- Subjects who are female and of childbearing age, are not postmenopausal or status-post sterilization will be tested for pregnancy prior to baseline imaging.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
- Children's Hospital of Philadelphia
Investigators
- Principal Investigator: Jason Parker, PhD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11163