Glioblastoma, IDH wild-type Glioblastoma, 18F-Fluciclovine PET, MRI
Conditions
Interventions
Fluciclovine PET-MRI contrast-enhanced imaging at 28-48 days following temozolomide-based concurrent chemoradiotherapy
Fluciclovine enhanced Magnetic Resonance Imaging/ Contrast - enhanced MRI
Sponsors
Sasayama Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed glioblastoma, IDH wild-type, who have undergone maximal safe tumor resection via craniotomy and have completed concurrent temozolomide chemotherapy. 2. Patients in whom preoperative diagnosis reveals a tumor located supratentorially (cerebrum or diencephalon), with no tumor identified in the cerebellum, brainstem, optic nerve, olfactory nerve, or pituitary gland. 3. Patients aged between 18 and 75 years at the time of obtaining informed consent. 4. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, or 3 if solely attributable to neurological symptoms caused by the tumor. 5. Patients who are able to undergo PET/MRI imaging between 28 and 48 days after completion of concurrent chemoradiotherapy with temozolomide. 6. Patients who have provided written informed consent to participate in the clinical study. If the patient is unable to sign due to neurological symptoms despite being capable of understanding and agreeing to the study, a proxy signature confirming the patient's consent is acceptable.
Exclusion criteria
Exclusion criteria: 1. Patients who are found to have multiple lesions or peritoneal dissemination at the time of surgery. 2. Patients with active multiple cancers (synchronous multiple cancers, multiple primary cancers, or metachronous multiple cancers with a disease-free interval of less than five years). (However, lesions equivalent to carcinoma in situ that are considered cured by local treatment are not regarded as active multiple cancers.) 3. Patients with an eGFR of <= 30 mL/min/1.73 m2. 4. Patients with infections requiring systemic treatment. 5. Patients receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive agents for diseases other than brain tumors. 6. Patients who cannot receive gadolinium or fluciclovine due to drug allergies. 7. Other patients deemed inappropriate for inclusion by the investigators of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concordance rate between Fluciclovine PET and MRI images using MRI as the reference standard | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance rate between Fluciclovine PET and MRI images using PET as the reference standard Lesion detection rate by MRI Lesion detection rate by Fluciclovine PET Agreement between Fluciclovine PET and MRI images Progression-free survival (PFS) Overall survival (OS) (Exploratory Evaluation Items) Full cyclotron bin accumulation values (SUVmax, SUVmean) Optimal ratio of PET-positive tumor region SUV to background SUV (Target-to-background ratio; TBR): In this study, the cut-off value is set at 1.6. However, since the PET RANO does not include fluciclovine information, the optimal value will be reconsidered in the future based on updated information and data obtained from this study. ADC values from DWI images Blood flow values by ASL (ASL CBF values) MR spectroscopy Cho/Cr values, mIns/Cr values, NAA/Cr values (Safety Evaluation Items) Occurrence of safety-related events in this clinical study | — |
Contacts
Public ContactHiroaki Nagashima
Kobe University Hospital
Outcome results
None listed