UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT
Title of the study (Brief title)	Usefulness of 18F-FBPA-PET
Region	Japan

Condition
Condition	Head and Neck Cancer,Malignant glioma
Classification by specialty	Oto-rhino-laryngology Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of 18F-FBPA-PET for tumor selection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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)
Key secondary outcomes	1. Comparision with standardizd uptake value on 18F-FBPA-PET,11C-Methionine-PET and 18F-FDG-PET 2. To investigate of optium 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 validity of results based on the result of 18F-FBPA-PET

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	18F-FBPA-PET
Interventions/Control_2	11C-MET-PET
Interventions/Control_3	18F-FDG-PET
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion 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
Key exclusion criteria	1.To provide therapy evaluation 2.Patients with significant complications poorly controlled glycaemia poorly controlled hyperpiesia obstructive pulmonary disease kidney disease(chronic kidney failure, acute kidney injur, Nephrotic syndrome, diseases requiring dialysis) heart disease with symptomatic heart failure 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 patients who want partner to become pregnant 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
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshihiro Takai
Organization	Southern TOHOKU BNCT Research Center
Division name	Southern TOHOKU BNCT Research Center
Address	7-10 Yatsuyamada, Koriyama, Fukushima
TEL	024-934-5330
Email	y-takai@hirosaki-u.ac.jp

Public contact
Name of contact person	Yoshihiro Eto
Organization	Southern TOHOKU Research Institute for Neuroscience
Division name	Head office
Address	7-115 Yatsuyamada, Koriyama, Fukushima
TEL	024-934-5322
Homepage URL
Email	rinri@mt.strins.or.jp

Sponsor
Institute	Southern TOHOKU BNCT Research Center
Institute
Department

Funding Source
Organization	Southern TOHOKU Research Institute for Neuroscience
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 22 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040972