Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

NCT ID: NCT06474533

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2028-08-31

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.

Conditions

Intracranial Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Population 1: Participants with intracranial neoplasms

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

Fluorethyltyrosine (18-F)

Intervention Type: DRUG

Given intravenously (IV)

Positron Emission Tomography (PET)

Intervention Type: PROCEDURE

Undergo Imaging Procedure

Population 2: Participants with suspected glial neoplasms

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)

Fluorethyltyrosine (18-F)

Intervention Type: DRUG

Given intravenously (IV)

Positron Emission Tomography (PET)

Intervention Type: PROCEDURE

Undergo Imaging Procedure

Interventions

Fluorethyltyrosine (18-F)

Given intravenously (IV)

Intervention Type: DRUG

Positron Emission Tomography (PET)

Undergo Imaging Procedure

Intervention Type: PROCEDURE

Other Intervention Names

Fluoroethyltyrosine (FET); FET; O-(2-[18F]fluoroethyl)-L-tyrosine (FET); PET scan; PET

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.

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Hope

OTHER

Sponsor Role: lead

Responsible Party

Thomas Hope

Co-Principal Investigator, IND Holder

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Javier Villanueva-Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Louise Magat

Role: CONTACT

Louise.Magat@ucsf.edu

(415) 502-1822

Facility Contacts

Louise Magat

Role: primary

Louise.Magat@ucsf.edu

415-502-1822

Role: backup

cancertrials@ucsf.edu

(887) 827-3222

Other Identifiers

24924

Identifier Type: -

Identifier Source: org_study_id

NCI-2024-04996

Identifier Type: REGISTRY

Identifier Source: secondary_id