Summary

for people ages 3 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Thomas Hope

Description

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. Imaging agents, such as fluoroethyltyrosine, may help doctors see the tumor better during a positron emission tomography (PET) scan.

Official Title

Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

Details

PRIMARY OBJECTIVES:

  1. To determine if F-18 fluoroethyltyrosine (FET) PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology alone in population 1.

II. To determine if FET PET can accurately differentiate between low-grade and high-grade glial neoplasms in population 2.

SECONDARY OBJECTIVES:

  1. 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 alone in population 1 patients with recurrent low-grade gliomas (grades 1 and 2).

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.

Keywords

Intracranial Neoplasm Low Grade Glioma Recurrent Glioblastoma Recurrent World Health Organization (WHO) Grade II Glioma Recurrent WHO Grade III Glioma Glioblastoma Glioma Brain Neoplasms Neoplasms F-18 Fluoroethyltyrosine (FET) Positron Emission Tomography (PET)

Eligibility

You can join if…

Open to people ages 3 years and up

  • Age > 3 years.
  • Presence or suspicion of intracranial neoplasm planning to undergo either biopsy or surgical resection.
  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94115 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT04044937
Phase
Phase 2
Study Type
Interventional
Last Updated