Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms (UC-GlioFET)

Thomas Hope

Status and phase: Completed; Phase 2

Conditions: Intracranial Neoplasm; Recurrent World Health Organization (WHO) Grade II Glioma; Recurrent Glioblastoma; Low Grade Glioma; Recurrent WHO Grade III Glioma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04044937

171022

NCI-2018-01875 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.

Full description

PRIMARY OBJECTIVES:

I. To determine if F-18 fluoroethyltyrosine (FET) PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas.

II. To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas in population 2.

SECONDARY OBJECTIVES:

I. To determine if FET PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology or imaging follow-up in population 1.

II. To determine if FET PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.

OUTLINE:

Participants receive F-18 fluoroethyltyrosine intravenously (IV) over approximately 1 minute and undergo PET over 40 minutes. After completion of study treatment, participants are followed up periodically.

Enrollment: 143 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 3 years.

• Presence or suspicion of intracranial neoplasm in two populations.

  • Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered:

    • Recurrent metastatic lesions.
    • Recurrent high-grade gliomas (grades 3 and 4).
    • Recurrent low-grade gliomas (grades 1 and 2).

  • Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.

Exclusion criteria

• Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.

• Patient 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 patients who cannot tolerate the exam.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Population 1: Intracranial neoplasms (glial or metastatic disease)

Experimental group

Description:

Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.

Treatment:

Procedure: Positron Emission Tomography (PET)

Drug: F-18 Fluoroethyltyrosine (FET)

Population 2: Suspected glial neoplasms

Experimental group

Description:

Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.

Treatment:

Procedure: Positron Emission Tomography (PET)

Drug: F-18 Fluoroethyltyrosine (FET)