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

Primary Purpose

Glioblastoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fluciclovine F18
Positron Emission Tomography
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma

Eligibility Criteria

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

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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (fluciclovine F18 PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor volume
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.

Secondary Outcome Measures

Changes in F18 fluciclovine defined disease with surgery and radiation
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
To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.

Full Information

First Posted
April 23, 2019
Last Updated
September 18, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03926507
Brief Title
F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
Official Title
Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
September 18, 2023 (Actual)
Study Completion Date
September 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (fluciclovine F18 PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo PET/CT scan
Intervention Type
Other
Intervention Name(s)
Fluciclovine F18
Other Intervention Name(s)
(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
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT scan
Primary Outcome Measure Information:
Title
Tumor volume
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Changes in F18 fluciclovine defined disease with surgery and radiation
Description
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.
Time Frame
Baseline up to 6 months
Title
Post-radiation enhancing brain tissue
Description
To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Results from pathology
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Johnson
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34081125
Citation
Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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