Clinical trial

Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

Name

171022

Description

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.

Trial arms

Trial start

2018-10-29

Estimated PCD

2024-03-31

Trial end

2024-03-31

Status

Completed

Phase

Early phase I

Treatment

F-18 Fluoroethyltyrosine (FET)

Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner

Arms:

Population 1: Intracranial neoplasms (glial or metastatic disease), Population 2: Suspected glial neoplasms

Other names:

18F-FET, 18FET, 2''-[F18] Fluoro-ethyl-L-tyrosine, [18F]-Fluoro-ethyl-L-tyrosine, Fluorine-18 2''-Fluoroethyl-L-tyrosine, Fluoroethyltyrosine F18, O-(2[F18]fluoroethyl)-L-tyrosine

Positron Emission Tomography (PET)

All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.

Arms:

Population 1: Intracranial neoplasms (glial or metastatic disease), Population 2: Suspected glial neoplasms

Other names:

Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging

Size

143

Primary endpoint

Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1)

Up to 6 months

Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2)

Up to 6 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 143, 'type': 'ACTUAL'}}

Updated at

2024-06-07

1 organization

Organization

Thomas Hope