Clinical trial NCT04044937: Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
Official title: Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intracranial Neoplasm
Low Grade Glioma
Recurrent Glioblastoma
Recurrent World Health Organization (WHO) Grade II Glioma
Recurrent WHO Grade III Glioma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 143
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1)
timeFrame: Up to 6 months
measure: Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Binary characterization of follow-up imaging as positive/negative for tumor recurrence
timeFrame: Up to 6 months
measure: Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1)
timeFrame: Up to 6 months
measure: Degree of inter-rater reliability for tracer uptake
timeFrame: Up to 6 months
measure: Degree of inter-rater reliability for radiological interpretations
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas A Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: