臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 10, 2024
Last modified on	Jan. 10, 2024
Trial ID	jRCT2032230554

Scientific Title	Phase I clinical BNCT Trial to evaluate the safty of iBNCT001 and SPM-011, Accelerator-Based novel High-Power Neutron Source in patient with newly diagnosed glioblastoma (iBNCT-GBM-01)
Public Title	Phase I clinical BNCT Trial to evaluate the safty of iBNCT001 and SPM-011, Accelerator-Based novel High-Power Neutron Source in patient with newly diagnosed glioblastoma

Contact for Scientific Queries	Name	Sakurai Hideyuki
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1, Amakubo, Tsukuba-shi, Ibaraki
	Telephone	+81-29-853-7100
	E-mail	hsakurai@pmrc.tsukuba.ac.jp
Contact for Public Queries	Name	Hashimoto Koichi
	Affiliation	University of Tsukuba
	Address	2-1-1, Amakubo, Tsukuba-shi, Ibaraki
	Telephone	+81-29-853-3326
	E-mail	koichi.hashimoto@md.tsukuba.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 07, 2023
Actual date of first enrollment
Target sample size		18
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	- Karnofsky Performance Status is greater than 50. - Histologically diagnosed glioblastoma (IDH-wild glioblastoma WHO grade 4 according to WHO 2016 classification) (immunostaining negative for IDH-1) - Measurable target lesions by RANO criteria with the deepest contrast-enhanced lesion within 6 cm of the skin surface on postoperative contrast-enhanced MRI scan.
	Exclusion Criteria	- Multiple lesions, bilateral lesions, disseminated lesions on MRI images - Significant postoperative symptoms of increased intracranial presure - Patients with severe systemic diseases - Patients who have a hitory of radiotherapy to the brain - Patients who meet the following criteria on clinical examination a) White blood cell count less than 3,500/mm3 b) Platelet count less than 7,5000/mm3 c) AST and ALT greater than 2.5 times the upper limit of the institutional standard d) Total bilirubin 1.5 times or more than the upper limit of the facility standard e) BUN 2.5 times or more than the upper limit of the facility standard f) Creatinine 1.5 times or more than the upper limit of the facility standard - Patients for whom contrast-enhanced MRI cannot be performed - Patients who cannot administrate temozolomide - Patients with ongoing convulsive seizures - Patients with active multiple cancers other than the target disease - Patients receiving or scheduled to receive bevacizumab - Pregnant women or patients who are unable to use contraception during the study period - Patients with phenylketonuria
	Age Minimum	18age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Newly-diagnosed glioblastoma
Intervention(s)		- Intravenous administration of investigational drug - Neutron irradiation of the clinical target volume with the investigational device
Health Condition(s) Keyword		boron, neutron, glioblastoma
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Occurrence rate of dose-limiting toxicity
Secondary Outcome(s)		Safety endpoints - Safety and tolerability after BNCT - Measurements of clinical laboratory tests - Measurements of physical examination and other investigations Efficacy endpoints - Overall survival - Progression-free survival - Local control at 90 days after BNCT - KPS measurements and change from baseline - Neurological examination measurements and change from baseline - Tumor responce evaluation - Duration of response

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Clinical Trial & Research Network IBARAKI Central Review Board
Address	2-1-1 Amakubo, Tsukuba-shi, Ibaraki, Ibaraki
Telephone	+81-29-853-3749
E-Mail	ibarakichiken@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none