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Fluoroethyltyrosine in Detecting Tumors in Participants With Recurrent Intracranial Tumors

Primary Purpose

Intracranial Neoplasm, Low Grade Glioma, Recurrent Glioblastoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
F-18 Fluoroethyltyrosine (FET)
Positron Emission Tomography (PET)
Sponsored by
Thomas Hope
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Neoplasm

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic FET PET

Arm Description

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.

Outcomes

Primary Outcome Measures

Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 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]
Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2)
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

Binary characterization of follow-up imaging as positive/negative for tumor recurrence
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.
Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1)
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]

Full Information

First Posted
July 25, 2019
Last Updated
November 7, 2022
Sponsor
Thomas Hope
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1. Study Identification

Unique Protocol Identification Number
NCT04044937
Brief Title
Fluoroethyltyrosine in Detecting Tumors in Participants With Recurrent Intracranial Tumors
Official Title
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Hope

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Neoplasm, Low Grade Glioma, Recurrent Glioblastoma, Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic FET PET
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
F-18 Fluoroethyltyrosine (FET)
Other Intervention Name(s)
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
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography, Positron Emission Tomography Scan, proton magnetic resonance spectroscopic imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1)
Description
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]
Time Frame
Day 1
Title
Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2)
Description
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]
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Binary characterization of follow-up imaging as positive/negative for tumor recurrence
Description
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.
Time Frame
Up to 6 months
Title
Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1)
Description
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]
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Aslam
Phone
877-827-3222
Email
Maya.Aslam@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Hope, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Aslam
Phone
877-827-3222
Email
Maya.Aslam@ucsf.edu
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Thomas A. Hope, MD
First Name & Middle Initial & Last Name & Degree
Javier Villanueva-Meyer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Fluoroethyltyrosine in Detecting Tumors in Participants With Recurrent Intracranial Tumors

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