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Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

ConditionIntracranial Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorThomas Hope

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.

Recurrent metastatic lesions.

Recurrent high-grade gliomas (Grades 3 and 4).

Recurrent low-grade gliomas (Grade 2).

Disqualifiers

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.

Trial population

Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fluorethyltyrosine (18-F)

    Drug

    Given intravenously (IV)

  • Positron Emission Tomography (PET)

    Procedure/Surgery

    Undergo Imaging Procedure

Treatment groups

199 Participants
are divided into 2 treatment groups
Group A: Population 1: Participants with intracranial neoplasms2 interventions
Group B: Population 2: Participants with suspected glial neoplasms2 interventions

Trial outcomes

Primary outcomes

1

Maximum Intracranial lesion tumor-to-background ratio (TBRmax)

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.

Time frame
Up to 3 years
2

Percentage of accurate prediction of presence of tumor (Population 1)

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

Time frame
Up to 3 years
3

Percentage of radiological read responses

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.

Time frame
Up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Hope

Lead sponsor

University of California, San Francisco

Sponsor institution

Source ClinicalTrials.gov
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