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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00335 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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Low Accrual
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| Name | Class |
|---|---|
| American Brain Tumor Association | OTHER |
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This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive for PTEN deletion | Confirmed by immunohistochemistry of tissue biopsy |
| |
| Negative for PTEN deletion | Confirmed by immunohistochemistry of tissue biopsy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-citrate PET/MR | Drug | Study participants will undergo the 68Ga-citrate PET/MR imaging after all screening and baseline assessments have been completed. Patient shall begin imaging between 120 and 360 minutes after the injection of the radiopharmaceutical. Coverage for the scan will extend from the patient's vertex to the neck. The entire imaging study will take roughly 90 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum standardized uptake value (SUVmax) | The location and extent of 68Ga-citrate uptake will be compared to both same day magnetic resonance imaging (MRI) and subsequent pathology. SUVmax will be the outcome of interest and summarized with descriptive measures. SUVmax will be compared via a two-sided two-sample equal-variance t-test between those patients positive for PTEN deletion and those negative for PTEN deletion. | 1 day |
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Inclusion Criteria:
Cohort A:
- Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy
Cohort B:
- Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy
Exclusion Criteria:
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Adults with WHO grade 3 or 4 glioma planning to undergo surgery with availability of immunohistochemistry of tissue
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| Name | Affiliation | Role |
|---|---|---|
| Susan Chang, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2019 | Apr 29, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |