Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms

NCT04044937 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 171022NCI-2018-01875
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Neoplasm; Low Grade Glioma; Recurrent Glioblastoma; Recurrent World Health Organization (WHO) Grade II Glioma; Recurrent WHO Grade III Glioma

Outcome Measures

Primary Outcomes (2)

• Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)

  Sensitivity is defined as a percentage of all participants with a true positive (TP) FET PET scan result relative to participants with a positive CSOT result = \[TP / (TP + FN)\] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.

  Up to 6 months

• Specificity of FET PET using a CSOT (subject-level)

  Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to participants with a negative CSOT result = \[TN / (TN + FP)\] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.

  Up to 6 months

Secondary Outcomes (25)

• Sensitivity of FET PET using a histopathology standard of truth (subject-level)

  Up to 6 months

• Sensitivity of FET PET using a histopathology standard of truth (lesion-level)

  Up to 6 months

• Specificity of FET PET using a histopathology standard of truth (subject-level)

  Up to 6 months

• Specificity of FET PET using a histopathology standard of truth (lesion-level)

  Up to 6 months

• Positive Predictive Value (PPV) using a histopathology standard of truth (subject-level)

  Up to 6 months

Study Arms (2)

Population 1: Intracranial neoplasms (glial or metastatic disease)

EXPERIMENTAL

Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.

Drug: F-18 Fluoroethyltyrosine (FET); Procedure: Positron Emission Tomography (PET)

Population 2: Suspected glial neoplasms

EXPERIMENTAL

Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.

Drug: F-18 Fluoroethyltyrosine (FET); Procedure: Positron Emission Tomography (PET)

Interventions

F-18 Fluoroethyltyrosine (FET) DRUG

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

Also known as: 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

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

Positron Emission Tomography (PET) PROCEDURE

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.

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging

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

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Thomas Hope: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma

Interventions

(18F)fluoroethyltyrosine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas A Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 5, 2019
• Study Start: October 29, 2018
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)