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| Name | Class |
|---|---|
| NovoCure Ltd. | INDUSTRY |
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In this research study, we will track the build-up of tryptophan, a radioactive tracer, in the brain using positron emission tomography (PET) scanning. Tryptophan, in its natural state, is an amino acid (one of the building blocks of proteins) that is normally present in the brain, and is used by the brain cells to create various other compounds. This process is altered in the presence of a brain tumor. By using a form of tryptophan marked with a small amount of radiation, we will be able to track this process during the course of the PET scan. This research will help determine if AMT PET is a useful method to recognize and differentiate between various types of brain tumors. In addition, to study the mechanisms of altered tryptophan uptake in the tumor and brain, we will also measure tryptophan levels and related molecules in your blood (obtained as a part of the PET procedure) and tumor tissue (in case you will have surgery to remove the tumor). This will help us to find new approaches to treat brain tumors in the future by altering abnormal tryptophan metabolism.
If you agree to take part in this research study, you will be asked to have:
1. A PET scan, 2. brief clinical questionnaires, and 3. biochemical studies of blood and tumor tissue. You will also have a second PET scan later, 2-3 months after the start of NovoTTF therapy, to determine if there are changes in the tumor that can be detected by PET. Your ability to participate in the study will be based, in part, on the results of the magnetic resonance images (MRI) in your medical chart from earlier clinical procedures. Once we receive the results of the PET scan, these will be compared to the MRI in order to help us analyze the tryptophan uptake in your brain. It will take about 3 hours to complete the PET scan; this includes the completion of the questionnaire, preparation and scanning. The actual scanning time will be 70 minutes. If you are a female of child-bearing age, we will need a small urine sample from you before starting the PET scanning procedure to make absolutely sure that you do not have unknown pregnancy for which radiation exposure might be harmful.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovoTTF | NovoTTF treatment will be administered as usual during the imaging study either in monotherapy or in combination with other treatments (initiated prior to NovoTTF therapy). The treatment plan or intervention will not be altered in any way. Two AMT-PET scans will be added to the management scheme: a baseline PET shortly before and a follow-up PET scan 2-3 months after the start of NovoTTF treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Interval Changes of Tumoral Metabolism | To measure interval changes of tumoral metabolism, blood flow, and metabolites (NAA, choline, creatine, lipid, lactate) using AMT-PET, perfusion MRI, and 1H-MRS, respectively, in patients with recurrent GBM treated with NovoTTF. | 2-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Interval changes of tumoral tryptophan metabolism | To evaluate if interval changes of tumoral tryptophan metabolism, perfusion, and/or metabolites as well as histopathologic features (e.g., blood vessel density) have a predictive value for progression-free and overall survival in patients treated with NovoTTF. | 2-3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible and agreeable to undergo NovoTTF treatment at KCC/WSU due to recurrent glioblastoma (initial or subsequent tumor recurrence) will be recruited by the multidisciplinary neuro-oncology team to undergo the two AMT-PET studies.
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| Name | Affiliation | Role |
|---|---|---|
| Csaba Juhasz, MD, PhD | Wayne State University | Principal Investigator |
| Sandeep Mittal, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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we will collect and analyze the tumor specimens obtained prior to NovoTTF therapy (as well as any tissue specimens available if a patient undergoes surgical resection after initiating NovoTTF therapy) for various histopathologic features (e.g., proliferative activity, vessel density, expression of L-type amino acid transporter), and correlate with neuroimaging findings and clinical response to NovoTTF. This may provide additional useful information on potential mechanisms of treatment failure.
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |