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Fluoroethyltyrosine in Detecting Tumors in Participants With Recurrent Intracranial Tumors

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ClinicalTrials.gov Identifier: NCT04044937
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

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. Imaging agents, such as fluoroethyltyrosine, may help doctors see the tumor better during a positron emission tomography (PET) scan.

Condition or disease Intervention/treatment Phase
Intracranial Neoplasm Low Grade Glioma Recurrent Glioblastoma Recurrent World Health Organization (WHO) Grade II Glioma Recurrent WHO Grade III Glioma Drug: F-18 Fluoroethyltyrosine (FET) Procedure: Positron Emission Tomography (PET) Phase 2

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 alone in population 1.

II. To determine if FET PET can accurately differentiate between low-grade and high-grade glial neoplasms 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 alone in population 1 patients with recurrent low-grade gliomas (grades 1 and 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 199 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic FET PET
All participants 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)
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
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

Procedure: 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.
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography
  • Positron Emission Tomography Scan
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1) [ Time Frame: Day 1 ]
    Radiologists will classify lesions based on imaging as either having recurrent disease or not having recurrent disease. True Positives (TP) are defined as an FET PET read positive for tumor and pathology/follow-up demonstrates tumor recurrence in at least one biopsy sample, False positives (FP) are defined as an FET PET read positive for tumor and pathology/follow-up demonstrates negative tumor recurrence in all of the biopsy samples, True negatives (TN) are defined as an FET PET read as negative for tumor and pathology/follow-up also negative tumor recurrence in all of the biopsy samples and a false negative (FN) is defined as an FET PET read as negative for tumor and pathology/follow-up demonstrates tumor recurrence in at least one biopsy sample. Misclassification rate = [FP+FN)]/[FP+FN+TP+TN]

  2. Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2) [ Time Frame: Day 1 ]
    Readers will have access only to FET PET images for Patients with suspected glial neoplasms (Grade 2-4) planning to undergo biopsy or surgery prior to primary treatment during evaluation and will grade the lesions in a binary fashion as having Grade II glial neoplasms or having Grade III/IV glial neoplasms. True positive (TP2): FET PET read as positive for Grade III/IV neoplasm, pathology demonstrates Grade III/IV neoplasm. False positive (FP2): FET PET read as positive for Grade III/IV neoplasm, pathology demonstrates Grade II neoplasm. True negative (TN2): FET PET read as positive for Grade II neoplasm, pathology demonstrates Grade II neoplasm. False negative (FN2): FET PET read as positive for Grade II neoplasm, pathology demonstrates Grade III/IV neoplasm. Misclassification rate = [FP2+FN2]/[FP2+FN2+TP2+TN2]


Secondary Outcome Measures :
  1. Binary characterization of follow-up imaging as positive/negative for tumor recurrence [ Time Frame: Up to 6 months ]
    In the absence of pathology, imaging will be used for correlation. Positive for tumor recurrence on follow-up imaging as correlate endpoint will be defined as a greater than 50% increase in the enhancing component of the lesion. If there is less than 50% increase in the enhancing component of the lesion, then it will be considered negative for tumor recurrence on follow-up. Follow-up imaging has to be performed within six months of the FET PET imaging study.

  2. Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1) [ Time Frame: Up to 6 months ]
    Low-grade glioma is defined by low uptake of FET. Radiologists will classify lesions based on imaging as either having recurrent disease or not having recurrent disease. True Positives (TP1L) are defined as an FET PET read positive for low-grade tumor and pathology/follow-up demonstrates low-grade tumor recurrence in at least one biopsy sample, False positives (FP1L) are defined as an FET PET read positive for low grade tumor recurrence and pathology/follow-up demonstrates negative low-grade tumor recurrence in all of the biopsy samples, True negatives (TN1L) are defined as an FET PET read as negative for low-grade tumor recurrence and pathology/follow-up also negative for low grade tumor recurrence in all of the biopsy samples and a false negative (FN1L) is defined as an FET PET read as negative for low grade tumor recurrence and pathology/follow-up demonstrates low grade tumor recurrence in at least one biopsy sample. Misclassification rate = [FP1L+FN1L)]/[FP1L+FN1L+TP1L+TN1L]



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044937


Contacts
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Contact: Maya Aslam 877-827-3222 Maya.Aslam@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Maya Aslam    877-827-3222    Maya.Aslam@ucsf.edu   
Contact       cancertrials@ucsf.edu   
Principal Investigator: Thomas A. Hope, MD         
Principal Investigator: Javier Villanueva-Meyer, MD         
Sponsors and Collaborators
Thomas Hope
Investigators
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Principal Investigator: Thomas A Hope, MD University of California, San Francisco
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Responsible Party: Thomas Hope, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04044937    
Other Study ID Numbers: 171022
NCI-2018-01875 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Glioblastoma
Glioma
Brain Neoplasms
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases