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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 : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE July 25, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • 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.
  • 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.
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluoroethyltyrosine in Detecting Tumors in Participants With Recurrent Intracranial Tumors
Official Title  ICMJE Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Intracranial Neoplasm
  • Low Grade Glioma
  • Recurrent Glioblastoma
  • Recurrent World Health Organization (WHO) Grade II Glioma
  • Recurrent WHO Grade III Glioma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: F-18 Fluoroethyltyrosine (FET)
  • Procedure: Positron Emission Tomography (PET)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2019)
199
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Hope, MD (415) 221-4810 ext 22648 Thomas.Hope@ucsf.edu
Contact: Namasvi Jariwala 415-514-6759 namasvi.jariwala@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04044937
Other Study ID Numbers  ICMJE 171022
NCI-2018-01875 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Hope, University of California, San Francisco
Study Sponsor  ICMJE Thomas Hope
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Hope, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP