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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04996 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
EXPLORATORY OBJECTIVES:
1. To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas.
OUTLINE:
Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET. Adult participants may undergo up to two repeat FET PET scans. Adverse events will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population 1: Participants with intracranial neoplasms | Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging. |
| |
| Population 2: Participants with suspected glial neoplasms | Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorethyltyrosine (18-F) | Drug | Given intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Intracranial lesion tumor-to-background ratio (TBRmax) | The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue. | Up to 3 years |
| Percentage of accurate prediction of presence of tumor (Population 1) | The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported | Up to 3 years |
| Percentage of radiological read responses | The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported. | Up to 3 years |
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Inclusion Criteria:
Presence or suspicion of intracranial neoplasm in two populations:
Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.
Three sub-populations will be considered:
Population 2: Participants prior to primary treatment with planned biopsy or surgical resection.
Age > 3 years.
Participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.
Exclusion Criteria:
Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.
Participants unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
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Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise Magat | Contact | (415) 502-1822 | Louise.Magat@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Javier Villanueva-Meyer, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | 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 |
|---|---|
| C000615276 | Fluorine-18 |
| C545932 | (18F)fluoroethyltyrosine |
| C117289 | O-(2-fluoroethyl)tyrosine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Positron Emission Tomography (PET) | Procedure | Undergo Imaging Procedure |
|
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |