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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035976
Receipt No. R000040972
Scientific Title Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT
Date of disclosure of the study information 2019/02/22
Last modified on 2019/02/22

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Basic information
Public title Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT
Acronym Usefulness of 18F-FBPA-PET
Scientific Title Clinical study to evaluate the usefulness of 18F-FBPA-PET for patient selection and expanding indication for BNCT
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshihiro Takai
Organization Southern TOHOKU BNCT Research Center
Division name Southern TOHOKU BNCT Research Center
Zip code
Address 7-10 Yatsuyamada, Koriyama, Fukushima
TEL 024-934-5330
Email y-takai@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Eto
Organization Southern TOHOKU Research Institute for Neuroscience
Division name Head office
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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