Recruiting

Fluoroethyltyrosine

Sponsor:

Thomas Hope

Code:

NCT06474533

Conditions

Intracranial Neoplasm

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

Interventions

Fluorethyltyrosine (18-F)

Positron Emission Tomography (PET)

Study Details

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.

Conditions

Intracranial Neoplasm

Study ID

NCT06474533

Start date

Jun 21, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

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

Enrollment

199 participants

Anticipated

Interventions and Outcome Measures

Arms

Population 1: Participants with intracranial neoplasms

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

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)

Interventions

Fluorethyltyrosine (18-F)

Given intravenously (IV)

Positron Emission Tomography (PET)

Undergo Imaging Procedure

Primary outcome measure

  • Maximum Intracranial lesion tumor-to-background ratio (TBRmax) [ Time Frame: Up to 3 years ]
  • Percentage of accurate prediction of presence of tumor (Population 1) [ Time Frame: Up to 3 years ]
  • Percentage of radiological read responses [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Louise Magat

(415) 502-1822Louise.Magat@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Louise Magat

415-502-1822Louise.Magat@ucsf.edu

(887) 827-3222cancertrials@ucsf.edu

Principal Investigator:

Michael Thomas, MD

More Information

Sponsor

Thomas Hope

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Imaging Studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thomas Hope on 2026-08-27.