PET detection of early local response of boron neutron capture therapy for recurrent malignant glioma

JRCT ID: jRCTs051220019

Registered date:28/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Recurrent malignant glioma after standard treatment
• Date of first enrollment: 09/08/2022
• Target sample size: 21
• Study type: Interventional
• Intervention(s): BNCT is performed in combination with a cyclotron neutron irradiation system (NeuCure) and a boron drug (Steboronin) in patients with recurrent malignant glioma after standard treatment. The drug administration (500 mg BPA/kg) and irradiation conditions (maximum skin dose 8.5 Gy-eq) will be the same as in the previous clinical trial, and the tumor shrinkage status after BNCT will be followed up for 3 months after BNCT. For that purpose, 18F-FBPA-PET, which can grasp the amino acid metabolic activity of tumor cells, is used. The response rate is calculated based on the maximum effect, and is compared with the preset threshold response rate of the effectiveness judgment. The study period for each patient is limited to MRI and FBPA-PET 3 months after BNCT.

Outcome(s)

Primary Outcome

Response rate is defined as CR + PR ratio for all cases, based on the maximum effect calculated from
T/N (tumor SUV / contralateral normal brain SUV mean) with 18F-BPA-PET 3 months after BNCT
CR: T/N is 1.0 or less
PR: Decrease of T/N is 25 percent or more
SD: Other than CR, PR, or PD
PD: Increase of T/N is 25 percent or more

• Secondary Outcome: Best response rate using MRI images after BNCT

Key inclusion & exclusion criteria

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

Include criteria

1. A histopathological diagnosis of malignant glioma has been obtained.
2.Receiving bevacizumab treatment for recurrence after standard treatment.
3. Having an evaluable lesion, which obviously recurred by MRI after bevacizumab administration.
Recurrence is defined as progression disease (PD) in RANO criteria by MRI.
4. Surgical treatment is difficult.
5. The age at the time of obtaining consent is between 20 and 79 years old.
6. Written consent has been obtained from the patient or the legal representative for participation in
the research.
7. Karnofsky performance status is 60 percent or higher.
8. No obvious tumor growth is observed on the contralateral cerebral hemisphere or infratentorial area by MRI (no contrast-enhanced/contrast-enhanced).
9. Expected to survive for 3 months or more, and to visit outpatient clinic 3 months after BNCT.
10. The functions of major organs are maintained, and the clinical laboratory test values meet the following conditions at the time of obtaining consent.
White blood cell count >= 3,000/microL
Neutrophil count >= 1,500/maicroL
Hemoglobin >= 8.0 g/dL
Platelet count >= 100,000/microL
AST =< 100 IU/L
ALT =< 100 IU/L
Total bilirubin =< 1.5 mg/dL
Serum creatinine =< 1.5 mg/dL
Proteinuria =< +

Exclude criteria

Patients with the following medical conditions or circumstances are excluded.
1. Medullary cavity dissemination.
2. Infections that require intravenous administration of antibiotics, antiviral drugs, antifungal drugs, etc.
3. Serious complications (heart disease, pulmonary fibrosis / interstitial pneumonia, bleeding tendency, uncontrolled hypertension, diabetes, etc.).
4. Phenylketonuria.
5. Currently bleeding (intracranial bleeding, gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, hemoptysis, etc.).
6. Even with oral anticoagulants, poor control or PT-INR is over 2.5.
7. History of severe hypersensitivity to MRI contrast medium, ingredients of Steboronine or 18F-FBPA.
8. Pregnant women or lactating women.
9. Participating in other clinical trials.
10. In addition, the patient judged by the principal investigator or the doctor in charge to be inappropriate for conducting this research safely.

Related Information

• Primary Sponsor: Nihei Keiji