Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT
- Conditions
- Head and Neck Cancer,Malignant glioma
- Registration Number
- JPRN-UMIN000035976
- Lead Sponsor
- Southern TOHOKU BNCT Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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