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Clinical trial

Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

ID
Name
24924
Description
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.
Trial arms
Trial start
2024-08-31
Estimated PCD
2028-08-31
Trial end
2028-08-31
Status
Not yet recruiting
Treatment
Fluorethyltyrosine (18-F)
Given intravenously (IV)
Arms:
Population 1: Participants with intracranial neoplasms, Population 2: Participants with suspected glial neoplasms
Other names:
Fluoroethyltyrosine (FET), FET, O-(2-[18F]fluoroethyl)-L-tyrosine (FET)
Positron Emission Tomography (PET)
Undergo Imaging Procedure
Arms:
Population 1: Participants with intracranial neoplasms, Population 2: Participants with suspected glial neoplasms
Other names:
PET scan, PET
Size
199
Primary endpoint
Maximum Intracranial lesion tumor-to-background ratio (TBRmax)
Up to 3 years
Percentage of accurate prediction of presence of tumor (Population 1)
Up to 3 years
Percentage of radiological read responses
Up to 3 years
Eligibility criteria
Inclusion Criteria: 1. Presence or suspicion of intracranial neoplasm in two populations: a. Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI. Three sub-populations will be considered: i. Recurrent metastatic lesions ii. Recurrent high-grade gliomas (Grades 3 and 4) iii. Recurrent low-grade gliomas (Grade 2) b. Population 2: Participants prior to primary treatment with planned biopsy or surgical resection. 2. 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: 1. Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans. 2. Participants unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation. 1. Sedation or anesthesia can be used for participants who cannot tolerate the exam.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 199, 'type': 'ESTIMATED'}}
Updated at
2024-06-25

1 organization

1 product

1 indication

Organization
Thomas Hope
Product
Fluorethyltyrosine
Indication
Intracranial Neoplasm