Usefulness of 18F-FBPA-PET

JRCT ID: jRCTs031180302

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and Neck Cancer, Malignant glioma
• Date of first enrollment: 04/01/2017
• Target sample size: 20
• Study type: Interventional

Intervention(s)

18F-FBPA-PET,11C-MET-PET are conducted at Southern TOHOKU hospital as an outpatient.18F-FBPA is administered in a range of 185-370 MBq with a concentration of less than 4 MBq/kg of a standard dose. Sixty minutes' dynamic scanning of local lesion is performed immediately after the administration of
FBPA and then 20 min whole-body scanning is done.
Three hundred seventy MBq of 11C-MET is administered as a standard dose and dynamic scanning of local lesion (whole body as necessary) is conducted 20 min after the end of administration.

Outcome(s)

Primary Outcome

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

1. Comparison with standardized uptake value on 18F-FBPA-PET,11C-Methionine-PET and 18F-FDG-PET
2. To investigate of the optimum 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 the validity of the results based on the result of 18F-BPA PET study.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include 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.

Exclude criteria

1. To provide therapy evaluation
2. Patients with significant complications
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
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

Related Information

• Primary Sponsor: Takai Yoshihiro
• Secondary ID(s): UMIN000035976