Clinical trial NCT06474533: Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Official title: Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Neoplasm
Keywords: Imaging Studies
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 199
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).

Brief summary: 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.

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.

Primary outcomes:
measure: Maximum Intracranial lesion tumor-to-background ratio (TBRmax)
timeFrame: Up to 3 years
measure: Percentage of accurate prediction of presence of tumor (Population 1)
timeFrame: Up to 3 years
measure: Percentage of radiological read responses
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Javier Villanueva-Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: