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

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ClinicalTrials.gov Identifier: NCT03926507
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date May 27, 2019
Actual Study Start Date  ICMJE April 30, 2019
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03926507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
Official Title  ICMJE Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Procedure: Computed Tomography
    Undergo PET/CT scan
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • 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
  • Procedure: Positron Emission Tomography
    Undergo PET/CT scan
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Computed Tomography
  • Other: Fluciclovine F18
  • Procedure: Positron Emission Tomography
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: April 23, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2020
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason M Johnson 713-792-8443 jjohnson12@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926507
Other Study ID Numbers  ICMJE 2018-0869
NCI-2019-01532 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0869 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

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