Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

Recruiting

• Conditions: Intracranial Neoplasm
• Interventions: Drug: Fluorethyltyrosine (18-F); Procedure: Positron Emission Tomography (PET)

• Registration Number: NCT06474533
• Lead Sponsor: Thomas Hope

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.

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Study Start: 2024-06-21
• Study First Posted: 2024-06-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population 1: Participants with intracranial neoplasms	Fluorethyltyrosine (18-F)	Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.
Population 1: Participants with intracranial neoplasms	Positron Emission Tomography (PET)	Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.
Population 2: Participants with suspected glial neoplasms	Fluorethyltyrosine (18-F)	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)
Population 2: Participants with suspected glial neoplasms	Positron Emission Tomography (PET)	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)

Primary Outcome Measures

Name	Time	Method
Percentage of accurate prediction of presence of tumor (Population 1)	Up to 3 years	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
Maximum Intracranial lesion tumor-to-background ratio (TBRmax)	Up to 3 years	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.
Percentage of radiological read responses	Up to 3 years	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States