Glioblastoma
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT scan
OTHERFluciclovine F18
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT scan
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Results from pathology | 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. |
Countries
United States
Outcome results
None listed