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Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT

Usefulness of 18F-FBPA-PET

20

Subjects: 14 Gender: 6 males, 8 females Median age: 63 (40-77) Evaluable lesions: 16 lesions Tumor localization: parotid gland 3, orbit 1, external auditory canal 1, oral cavity 1, nasopharynx 1, hypopharynx 1, larynx 1, retropharyngeal lymph node 4, level II lymph node 1, parapharyngeal space 2 Histology: SCC 13 cases, mucoepidermoid carcinoma 1 case, salivary ductal carcinoma 1 case, acinic cell carcinoma 1 case Tumor length: 23.2 mm (10.0-45.7) Tumor volume: 1.65 mL (0.21-16.2) Median number of days between 11C-MET-PET/CT and 18F-FDG-PET/CT, and 18F-FBPA-PET/CT: 1 (1-6)

The final patient enrollment date was September 23, 2020. Due to the time required for data analysis to be completed, the clinical study deadline was changed from the original date of December 4, 2020 to January 31,2022.

One subject showed respiratory distress due to symptoms of airway narrowing caused by exacerbation of the primary laryngeal tumor due to prolonged supine position during PET imaging.

- Primary endpoints 18F-FBPA-PET: (cervical FOV / trunk FOV) SUVmax = 4.5 +- 1.1 / 3.4 +- 0.8 T/N ratio = 3.6 +- 0.8 / 1.9 +- 0.6 SUVmean, SUVmin values: not worth evaluating 11C-Methionine-PET: (cervical FOV) SUVmax = 6.1 +- 2.3 T/N ratio = 6.8 +- 5.0 SUVmean, SUVmin values: not worth evaluating - Secondary endpoints 1) Comparison of the distribution of drug accumulation in 18F-FBPA-PET, 11C-MET-PET and 18F-FDG-PET / 3) Evaluation of the correlation between the above parameters and those obtained by 11C-MET-PET and 18F-FDG-PET performed in advance. Correlation between 18F-FBPA-PET and 11C-MET-PET SUVmax: r = 0.32, TNR: r = 0.72 Correlation between 18F-FBPA-PET and 18F-FDG-PET SUVmax: r = 0.13 (cervical FOV)/ 0.33 (trunk FOV) 2) 18F-FBPA-PET dynamic study to determine optimal conditions for monitoring boron concentration The SUV value in the tumor increased immediately after the administration of 18F-FBPA up to 15 minutes, and almost disappeared after 30 minutes, and the tumor tissue boron concentration reached equilibrium and was maintained until 60 minutes. 3) Investigation of tumor dosimetry in BPA-BNCT based on 18F-BPA PET results and evaluation of the validity of the calculated results According to the recovery coefficient curves of Discovery 610 (GE) and uMI780 (United Imaging), the tumor size to ensure quantitative SUVmax should be at least 22 mm and 17 mm in short diameter, respectively, and tumor homogeneity should be maintained. Since only a few cases meet these conditions, the quantitative SUVmax required for tumor dosimetry is not ensured and is not valid for tumor dose calculation.

In the 16 evaluable lesions, the SUVmax of 18F-FBPA was 4.5 +-1.1 using the cervical FOV and 3.4 +- 0.8 using the trunk FOV. The tumor-to-normal tissue ratio (TNR) was 3.6 +- 0.8 for the cervical FOV. The Tumor-to-blood ratio by ascending aorta (TBRAAo) was 3.0 +- 0.8, and TBR by left ventricle (TBRLV) was 2.8 +- 0.8. The correlation coefficient for SUVmax between 18F-FBPA-PET and 11C-MET-PET was 0.32; that for TNR was 0.72. The correlation to 18F-FDG-PET was 0.13 at cervical FOV and 0.33 at trunk FOV.

April. 01, 2022

Yes

De-identified (anonymized) or coded (pseudonymized) individual clinical trial participant data would be shared when needed, upon request from researchers, authorized by the principal investigator of this study.

https://jrct.niph.go.jp/latest-detail/jRCTs031180302

Takai Yoshihiro

Southern TOHOKU BNCT Research Center

7-10 Yatsuyamada, Koriyama, Fukushima

y-takai@hirosaki-u.ac.jp

Eto Yoshihiro

Southern TOHOKU Research Institute for Neuroscience

7-115 Yatsuyamada, Koriyama, Fukushima

+81-24-934-5322

yoshihiro.eto@mt.strins.or.jp

Complete

Dec. 05, 2016

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

diagnostic purpose

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.

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

Both

Head and Neck Cancer, Malignant glioma

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.

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)

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.

+81-43-206-4706

Mar. 12, 2019

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