Glioblastoma Glioblastoma, fluciclovine, PET
Conditions
Interventions
F-PET is performed preoperatively, and PET-positive area is removed. F-PET is performed postoperatively. The postoperative F-PET is interpreted by three neurosurgery specialists. If the postoperative
Sponsors
Ryuta Saito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria 1) Preoperative contrast MRI indicates suspicion of primary glioblastoma. 2) Predicted resection rate of 18F-fluciclovine PET positive lesions is 95% or higher without deterioration of major neurological symptoms. 3) Preoperative contrast MRI shows no evidence of multiple lesions or dissemination. 4) Age 18 years or older and 75 years or younger on the day of registration. 5) Performance status (PS) is either 0-2 according to ECOG criteria, or PS 3 due to neurological symptoms caused by the tumor (PS must be recorded in the medical record). 6) No history of chemotherapy, including treatment for other types of cancer, or radiation therapy to the head. 7) The most recent test results within 14 days prior to registration (the same day of the week two weeks prior to the registration date is acceptable) must meet all of the following. 1. Neutrophil count over 1,500 /mm3 2. Hemoglobin count over 8.0 g/dL 3. Platelet count count over 100000 /mm3 4. AST under 120 U/L 5. ALT under 120 U/L 6. Serum creatinine under 2.0 mg/dL 8) Written consent has been obtained from the patient to participate in the study. However, if the patient is able to understand and consent to the study, but has difficulty signing due to neurological symptoms, a scribe may sign the consent form on their behalf.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be enrolled in this study. 1) Having an active cancer. 2) Having an infection requiring systemic treatment. 3) Having a fever of 38.0 or higher at the time of enrollment. 4) Women who are pregnant, may be pregnant, within 28 days of giving birth, or breastfeeding. Men who wish to impregnate their partners. 5) Having psychiatric disorders or symptoms that interfere with daily life and are deemed to make it difficult to participate in the study. 6) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressants for diseases other than brain tumors. 7) Having poorly controlled diabetes. 8) Having unstable angina (angina that has developed or worsened within the past 3 weeks) or a history of myocardial infarction within the past 6 months. 9) Having one or more of interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest X-ray. 10) Accumin or gadolinium cannot be used due to drug allergies. 11) HIV antibody positive. 12) HBs antigen positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival time, type of recurrence (local or distant), adverse event by pre- and post-operative 18F-Fluciclovine PET. Overall survival, recurrence/progression-free survival, and recurrence/progression pattern in the patient group in which total resection was confirmed by postoperative F-PET (including cases in which postoperative inflammatory focus was diagnosed by postoperative F-PET), the patient group in which residual tumor was diagnosed by postoperative F-PET and underwent reoperation, and the patient group in which residual tumor was diagnosed by postoperative F-PET and did not underwent reoperation | — |
Contacts
Public ContactDeguchi Shoichi
Nagoya University Graduate School of Medicine
Outcome results
None listed