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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 : August 5, 2019
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
Estimated Enrollment : 199 participants
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 : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic FET PET
Participants receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes.
Drug: F-18 Fluoroethyltyrosine (FET)
Patients given a one-time injected dose of 4 to 7 millicurie (mCi) of FET. 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)
Patient receives single PET imaging lasting for 40 minutes
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. Binary characterization of study as positive/negative for recurrence disease in three groups of patients with intracranial neoplasms with concern for recurrence or progression on conventional imaging (Population 1) [ Time Frame: Day 1 ]
    Patients in population 1 will be grouped into high-grade gliomas, low-grade gliomas, or metastatic disease. Radiological readers will have access only to FET PET images during evaluation and will grade the lesions in a binary fashion as having recurrent disease or not having recurrent disease. Misclassification rate, sensitivity, specificity, positive predictive value, negative predictive value and accuracy will be calculated for the detection of recurrent disease. 95% percent confidence intervals will be created.

  2. Binary characterization of study as positive/negative for high grade glial neoplasms in patients prior to primary treatment with planned biopsy or surgical resection (Population 2) [ Time Frame: Day 1 ]
    Low-grade glioma is defined by low uptake of FET on all time-points, or progressive increase in SUVs of the lesion at each of the three imaging time points during the dynamic PET acquisition. Misclassification rate, sensitivity, specificity, positive predictive value, negative predictive value and accuracy will be calculated for the detection of Grade III/IV neoplasm in population 2. 95% percent confidence intervals will be created.

  3. Intracranial lesion standardized uptake values (SUV): SUVvolume, SUVmax and SUVpeak at each imaging time point. [ Time Frame: Day 1 ]
    Measuring uptake of FET on all time-points, or are defined by progressive increase in radiotracer uptake of the lesion at each of the three imaging time points (time points refers to perfusion, equilibrium and washout time points of the dynamic PET acquisition)


Secondary Outcome Measures :
  1. Binary characterization of follow-up imaging as positive/negative for tumor recurrence [ Time Frame: Up to six months ]
    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, sensitivity, specificity, positive predictive value, negative predictive value and accuracy for FET PET in the evaluation of recurrence of low-grade gliomas. [ Time Frame: Up to six months ]
    Low-grade glioma is defined by low uptake of FET on all time-points (three imaging time points: perfusion, equilibrium and washout time points of the dynamic PET acquisition). Positive for tumor recurrence on follow-up imaging 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.



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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 planning to undergo either biopsy or surgical resection.

    • 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: Thomas Hope, MD (415) 221-4810 ext 22648 Thomas.Hope@ucsf.edu
Contact: Raven Smith (415) 353-9448 Raven.Smith@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Thomas Hope, MD    415-221-4810 ext 22648    Thomas.Hope@ucsf.edu   
Contact: Raven Smith    (415) 353-9448    Raven.Smith@ucsf.edu   
Principal Investigator: Thomas A. Hope, MD         
Sponsors and Collaborators
Thomas Hope
Investigators
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Principal Investigator: Thomas 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     History of Changes
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: August 5, 2019
Last Verified: August 2019
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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Brain Neoplasms
Neoplasms
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
Glioblastoma
Glioma
Astrocytoma
Central Nervous System Diseases
Nervous System Diseases