UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031323
Receipt number 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 18:18:46

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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