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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031323
Receipt No. R000035695
Scientific Title Adaptive evaluation of Boron Neutron Capture Therapy (BNCT) using F-18 FBPA PET
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/15

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Basic information
Public title Adaptive evaluation of Boron Neutron Capture Therapy (BNCT) using F-18 FBPA PET
Acronym Adaptive evaluation of BNCT using FBPA PET
Scientific Title Adaptive evaluation of Boron Neutron Capture Therapy (BNCT) using F-18 FBPA PET
Scientific Title:Acronym Adaptive evaluation of BNCT using FBPA PET
Region
Japan

Condition
Condition Brain tumor
Head and neck tumor
Other tumors(digestive organs, lung, skin, blood tumor etc.)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Dermatology Oto-rhino-laryngology
Radiology Oral surgery Neurosurgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In individual cases, FBPA PET is used to estimate the accumulation of boron compound (boronophenylalanine, BPA) within the tumor and to evaluate the indication for boron neutron capture therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Estimation of boron (10 B) concentration in tumor
Adaptive evaluation of BNCT
Key secondary outcomes Prediction of side effects of BNCT in normal tissues

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 FBPA is administered intravenously to the tumor patients.
Tumor patients are imaged using PET-CT.
Interventions/Control_2
Interventions/Control_3
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. 50 tumor patients who can not expect the effect of other treatments (surgery, radiotherapy, and chemotherapy)
2. Age; 20-70 years-old
3. Written informed consent is obtained.
4. Tumor patients not applicable to exclusion items
Key exclusion criteria 1. A pregnant woman, a lactating subject, or a person who wishes to become pregnant
2. Child
3. A patient who should not be recruited to the clinical trial as determined by the investigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Graduate School of Medicine
Division name Department of Nuclear Medicine and Tracer Kinetics
Zip code
Address 2-2 Yamadaoka Suita Osaka, Japan
TEL 06-6879-3461
Email hatazawa@tracer.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Graduate School of Medicine
Division name Department of Nuclear Medicine and Tracer Kinetics
Zip code
Address 2-2 Yamadaoka Suita Osaka, Japan
TEL 06-6879-3461
Homepage URL
Email hatazawa@tracer.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Nuclear Medicine and Tracer Kinetics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 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
2018 Year 02 Month 15 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035695

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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