Summary

Eligibility
for people ages 3 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Thomas A Hope, MD
Headshot of Thomas A Hope
Thomas A 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. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to 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 in population 1 with recurrent metastatic disease and high-grade gliomas.

II. To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas 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 in population 1 with recurrent low-grade gliomas.

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, Neoplasms, Glioblastoma, Glioma, Brain Neoplasms, Recurrence, F-18 Fluoroethyltyrosine (FET), Positron Emission Tomography (PET), Population 2: Suspected glial neoplasms

Eligibility

You can join if…

Open to people ages 3 years and up

  • Age > 3 years.
  • Presence or suspicion of intracranial neoplasm in two populations.
    • 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.

Location

  • UCSF
    San Francisco California 94115 United States

Lead Scientist at UCSF

  • Thomas A Hope, MD
    Thomas Hope, MD, is the Vice Chair of Clinical Operations and Strategy in the Department of Radiology. He also serves as the Director of Molecular Therapy. He serves as Chief of Nuclear Medicine at the San Francisco VA Medical Center and as chair of the Cancer Center’s Molecular Imaging & Radionuclide Therapy Site Committee.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT04044937
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 143 people participating
Last Updated