Head and Neck Cancer,Malignant glioma
Conditions
Interventions
18F-FBPA-PET
11C-MET-PET
18F-FDG-PET
Sponsors
Southern TOHOKU BNCT Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient has voluntarily signed the informed consent 2.Patients'age 20=<,<80 3.Patients have histopathologically proven malignant tumors and tumor lesions more than 1cm in diameter on CT or MRI. 4.Patients who falls under any of the following categories A)Patients newly diagnosed with malignant tumors have not received anti-cancer therapy yet B)Patients newly diagnosed with tumor recurrence and progression by CT or MRI have not received newly anti-cancer therapy yet 5.Patients who have not previous history of radiotherapy or who have radiotherapy more than 3 months before 6.Patients with ECOG PS score 0-2 7.Patients who falls under any of the following categories: A)Patients who can be taken 2 PET examinations,11C-MET-PET and 18F-FBPA-PET within 3weeks after when 18F-FDG-PET study was conducted B)Patients who can be taken 18F-FDG-PET and 11C-MET-PET on the same day, in addition,can be taken F-FBPA-PET within 2 weeks of date of those examinations 8.Patients who can be held in supine position during PET examinations 9.Patients with stable main organ functions such as liver or kidney on hematologic test for the past 6 months: WBC>=3,000/mm3 and <=12,000/mm3 ANC>=1,500/mm3 Platelets>=100,000/mm3 AST(GOT)=<2.5 x the ULN for the reference lab ALT(GPT)=<2.5 x the ULN for the reference lab Creatinine =< 1.5mg/dL 10.Patients have no clinically significant abnormalities in 12-lead ECG for the past 6 months
Exclusion criteria
Exclusion criteria: 1.To provide therapy evaluation 2.Patients with significant complications poorly controlled glycaemia poorly controlled hyperpiesia obstructive pulmonary disease kidney disease(chronic kidney failure, acute kidney injur, Nephrotic syndrome, diseases requiring dialysis) heart disease with symptomatic heart failure 3.Patients with phenylketonuria 4.Patients who were enrolled in this clinical study or BNCT related study within 3 months after the initial informed consent or who are participating and will participate in other clinical study 5.Patients who are pregnancy and want to become pregnant and male patients who want partner to become pregnant 6.Patients with complications of mental disease or psychological symptom can't be participated in this clinical study or are taking antipsychotics 7.Patients with poorly controlled epilepsy 8.Patients whom an attending physician determined ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To obtain and evaluate the following parameters of tumors from 18F-FBPA-PET and 11C Methionine-PET study SUVmax,SUVmean,SUVminimum SUVtumor/SUVnormal tissue(T/N ratio) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparision with standardizd uptake value on 18F-FBPA-PET,11C-Methionine-PET and 18F-FDG-PET 2. To investigate of optium condition for a boron concentration monitoring method from 18F-FBPA-PET dynamic study 3. To evaluate the correlation between the parameters from FBPA-PET mentioned above and those parameters obtained from 11C-MET-PET and 18F-FDG-PET study 4. To evaluate the evaluation method for tumor dose calculation for BPA-BNCT and validity of results based on the result of 18F-FBPA-PET | — |
Countries
Japan
Contacts
Public ContactYoshihiro Eto
Southern TOHOKU Research Institute for Neuroscience Head office
Outcome results
None listed