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

Not Applicable

Completed

Interventions: Procedure: Computed Tomography
Other: Fluciclovine F18
Procedure: Positron Emission Tomography

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluciclovine F18 PET/CT)	Computed Tomography	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.
Diagnostic (fluciclovine F18 PET/CT)	Fluciclovine F18	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.
Diagnostic (fluciclovine F18 PET/CT)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
Tumor volume	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.

Secondary Outcome Measures

Name	Time	Method
Post-radiation enhancing brain tissue	Up to 6 months	To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.
Changes in F18 fluciclovine defined disease with surgery and radiation	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.