UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035976 |
|---|---|
| Receipt number | 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 16:13:45 |
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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
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
rinri@mt.strins.or.jp
Sponsor or person
Institute
Southern TOHOKU BNCT Research Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040972
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