F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery

October 7, 2024 updated by: M.D. Anderson Cancer Center

Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response

This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging.

SECONDARY OBJECTIVES:

I. To assess changes in F18 fluciclovine defined disease with surgery and radiation.

II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity.

EXPLORATORY OBJECTIVES:

I. To assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.

After completion of study, patients will be followed up at 3 and 6 months.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is a candidate for brain tumor resection and radiation with lesion suspected to be or previously biopsy proven to be a glioblastoma.
  • Patient is able to understand and give consent to participation in the study.

Exclusion Criteria:

  • Pregnant.
  • Known allergy to gadolinium-based contrast agents or F18 fluciclovine.
  • Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m^2.

  • Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:

    • Electronically, magnetically, and mechanically activated implants
    • Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
    • Metallic splinters in the eye
    • Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
    • Cochlear implants
    • Other pacemakers, e.g., for the carotid sinus
    • Insulin pumps and nerve stimulators
    • Non-MR safe lead wires
    • Prosthetic heart valves (if dehiscence is suspected)
    • Non-ferromagnetic stapedial implants
    • Pregnancy
    • Claustrophobia that does not readily respond to oral medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 IV and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.
Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PET SCAN
  • positron emission tomography scan
Other: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor volume
Time Frame: Up to 6 months
Will be assessed with fluciclovine F18 (F18 fluciclovine) positron emission tomography (PET) computed tomography (CT). The three volumes measured (amino acid hypermetabolic volume [AHV], T2 fluid attenuated inversion recovery [FLAIR] and T1 contrast [T1C]) will be compared to each other for each patient, and plotted as boxplots, both raw (as mL) and as normalized values (to the T1C volume) to facilitate comparisons between patients.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in F18 fluciclovine defined disease with surgery and radiation
Time Frame: Baseline up to 6 months
Will compare tumor volumes measured by this method between the initial time point and the three follow-up time points within patients using Wilcoxon rank-sum tests.
Baseline up to 6 months
Post-radiation enhancing brain tissue
Time Frame: Up to 6 months
To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.
Up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results from pathology
Time Frame: Up to 6 months
Will use rank correlation analysis to assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging. The association between tumor histology (glioma/non-glioma) and grade and tumor volumes from imaging results will be assessed using Wilcoxon rank-sum tests and rank correlation.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

September 18, 2023

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0869 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-01532 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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