Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

Thomas Hope

Status: Enrolling

Conditions: Intracranial Neoplasm

Treatments: Procedure: Positron Emission Tomography (PET); Drug: Fluorethyltyrosine (18-F)

Study type: Observational

Funder types: Other

Identifiers

NCT06474533

24924

NCI-2024-04996 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

199 participants in 2 patient groups

Population 1: Participants with intracranial neoplasms

Description:

Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.

Treatment:

Drug: Fluorethyltyrosine (18-F)

Procedure: Positron Emission Tomography (PET)

Population 2: Participants with suspected glial neoplasms

Description:

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)

Treatment:

Drug: Fluorethyltyrosine (18-F)

Procedure: Positron Emission Tomography (PET)