Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluorethyltyrosine (18-F), Positron Emission Tomography (PET).
- Who it may be relevant to
- Registry conditions: Intracranial Neoplasm. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
PRIMARY OBJECTIVES:
1. To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas. 2. To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2.
SECONDARY OBJECTIVES:
1. To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1. 2. To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.
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.
Interventions
- Drug Fluorethyltyrosine (18-F)
Given intravenously (IV) - Procedure Positron Emission Tomography (PET)
Undergo Imaging Procedure
Primary outcome measures
- Maximum Intracranial lesion tumor-to-background ratio (TBRmax) [Time frame: Up to 3 years]
- Percentage of accurate prediction of presence of tumor (Population 1) [Time frame: Up to 3 years]
- Percentage of radiological read responses [Time frame: Up to 3 years]
Eligibility criteria
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:
- Recurrent metastatic lesions.
- Recurrent high-grade gliomas (Grades 3 and 4).
- Recurrent low-grade gliomas (Grade 2).
- 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.
- Sedation or anesthesia can be used for participants who cannot tolerate the exam.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06474533 · 24924 · NCI-2024-04996