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

Phase 2

Recruiting

• Conditions: Recurrent malignant glioma after standard treatment

• Registration Number: JPRN-jRCTs051220019
• Lead Sponsor: ihei Keiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 21

Inclusion 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 =< +

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified