Clinical Trials Directory

Trials / Completed

CompletedNCT04044937

Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms

Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
143 (actual)
Sponsor
Thomas Hope · Academic / Other
Sex
All
Age
3 Years
Healthy volunteers
Not accepted

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 FET PET can differentiate between benign treatment-related changes (TRC) and recurrent glioma in comparison to a composite standard of truth (CSOT) that includes pathology and other clinical information, evaluated using estimates of sensitivity and specificity (Combined populations) SECONDARY OBJECTIVES: I. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.(Combined populations). II. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a CSOT evaluated using estimates other than subject-based sensitivity and specificity.(Combined populations). III. To assess the safety of FET PET, as determined by treatment emergent adverse events (TEAEs) within 48 hours of FET administration.(Combined populations). IV. To describe the inter-reader variability between 3 independent blinded readers of FET PET images in assessments of benign TRC versus recurrent glioma.(Combined populations). V. To describe intra-reader variability between 3 independent blinded readers of FET PET images in the assessments of benign TRC versus recurrent glioma.(Combined populations). EXPLORATORY OBJECTIVES: I. To assess relationships between serial FET PET and clinical outcome (benign TRC and recurrence) in patients with recurrent metastatic lesions, recurrent high grade gliomas and recurrent low-grade gliomas. II. To determine if MRI can differentiate between benign treatment-related changes and recurrence. III. To describe the distribution of the standardized uptake value (SUV) and tumor-to-background ratio (TBR) for observed lesions. IV. To determine if FET PET can differentiate between benign TRC and recurrent metastatic lesions. V. To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas (Population 2). 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.

Conditions

Interventions

TypeNameDescription
DRUGF-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
PROCEDUREPositron 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.

Timeline

Start date
2018-10-29
Primary completion
2024-03-31
Completion
2024-03-31
First posted
2019-08-05
Last updated
2026-03-11

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04044937. Inclusion in this directory is not an endorsement.