Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms

NCT ID: NCT04044937

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2024-03-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Population 1: Intracranial neoplasms (glial or metastatic disease)

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.

Group Type: EXPERIMENTAL

F-18 Fluoroethyltyrosine (FET)

Intervention Type: DRUG

Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner

Positron Emission Tomography (PET)

Intervention Type: PROCEDURE

All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.

Population 2: Suspected glial neoplasms

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.

Group Type: EXPERIMENTAL

F-18 Fluoroethyltyrosine (FET)

Intervention Type: DRUG

Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner

Positron Emission Tomography (PET)

Intervention Type: PROCEDURE

All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.

Interventions

F-18 Fluoroethyltyrosine (FET)

Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner

Intervention Type: DRUG

Positron Emission Tomography (PET)

All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.

Intervention Type: PROCEDURE

Other Intervention Names

18F-FET; 18FET; 2''-[F18] Fluoro-ethyl-L-tyrosine; [18F]-Fluoro-ethyl-L-tyrosine; Fluorine-18 2''-Fluoroethyl-L-tyrosine; Fluoroethyltyrosine F18; O-(2[F18]fluoroethyl)-L-tyrosine; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography; Positron Emission Tomography Scan; proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Hope

OTHER

Sponsor Role: lead

Responsible Party

Thomas Hope

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas A Hope, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2018-01875

Identifier Type: REGISTRY

Identifier Source: secondary_id

171022

Identifier Type: -

Identifier Source: org_study_id