Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Neoplasm
• Intervention / Treatment: Drug: Fluorethyltyrosine (18-F); Procedure: Positron Emission Tomography (PET)

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.

• Study Type: Observational
• Enrollment (Estimated): 199

Contacts and Locations

• Study Contact: Name: Louise Magat; Phone Number: (415) 502-1822; Email: Louise.Magat@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Louise Magat; Phone Number: 415-502-1822; Email: Louise.Magat@ucsf.edu
      • Principal Investigator: Javier Villanueva-Meyer, MD
      • Contact: Phone Number: (887) 827-3222; Email: cancertrials@ucsf.edu
      • Sub-Investigator: Thomas Hope, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Population 1: Participants with intracranial neoplasms; Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.	Drug: Fluorethyltyrosine (18-F); Given intravenously (IV); Other Names: Fluoroethyltyrosine (FET); FET; O-(2-[18F]fluoroethyl)-L-tyrosine (FET); Procedure: Positron Emission Tomography (PET); Undergo Imaging Procedure; Other Names: PET; PET scan
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)	Drug: Fluorethyltyrosine (18-F); Given intravenously (IV); Other Names: Fluoroethyltyrosine (FET); FET; O-(2-[18F]fluoroethyl)-L-tyrosine (FET); Procedure: Positron Emission Tomography (PET); Undergo Imaging Procedure; Other Names: PET; PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Intracranial lesion tumor-to-background ratio (TBRmax)	The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue.	Up to 3 years
Percentage of accurate prediction of presence of tumor (Population 1)	The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported	Up to 3 years
Percentage of radiological read responses	The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported.	Up to 3 years

Collaborators and Investigators

• Sponsor: Thomas Hope
• Investigators: Principal Investigator: Javier Villanueva-Meyer, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Imaging Studies
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy; (18F)fluoroethyltyrosine; Fluorine-18; O-(2-fluoroethyl)tyrosine
• Other Study ID Numbers: 24924; NCI-2024-04996 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No