UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory Study of Usefulness of 18F-BPA PET/CT in Clinical Staging of Malignancies
Acronym	Study of Usefulness of 18F-BPA PET/CT
Scientific Title	Exploratory Study of Usefulness of 18F-BPA PET/CT in Clinical Staging of Malignancies
Scientific Title:Acronym	Study of Usefulness of 18F-BPA PET/CT
Region	Japan

Condition
Condition	patients with malignancies
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm safety of F18-BPA PET/CT and to explore its usefulness in the diagnosis of malignancies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety of F18-BPA Biodistribution of F18-BPA Optimal imaging conditions of F18-BPA PET/CT
Key secondary outcomes	Comparison of F18-BPA and F18-FDG PET/CT Comparison and evaluation of F18-BPA accumulations in the target lesions and their clinical characteristics

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	Medicine
Interventions/Control_1	Injection of 3.7-5.55MBq/kg F18-BPA and PET/CT imaging study of 4 hours and blood examinations, and conventional F18-FDG PET/CT examination
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	2 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Written informed consent can be obtained Equal to or over 2 years and less tha 80 years Established diagnosis of malignancy by histology or cytology with evaluable lesions PS is 0-2 Quiet supine position can be kept during PET/CT examinations F18-FDG PET/CT can be performed within 2 weeks of F-18-BPA PET/CT Main organs functions must be normal EKG before F18-BPA injection must be normal
Key exclusion criteria	entered or entering to other clinical trials within 3 months Patients with uncontrollable diabetes or hypertension, with phenylketonuria, unstable angina, chronic renal disease or renal failure Patients who cannot undergo F18-FDG PET/CT Pregnant women or women who have the possibility to be pregnant Lactating women Patient who wants the partner be pregnant Patients with mental disorders whose entry to the clinical trial seems diffucult Patients who are considered to be ineligible by referring physician
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun ITAMI
Organization	National Cancer Center Hospital
Division name	Department of Radiation Oncology
Zip code
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	jitami@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Jun ITAMI
Organization	National Cancer Center Hospital
Division name	Department of Radiation Oncology
Zip code
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	jitami@ncc.go.jp

Sponsor
Institute	"Hotta Group" of National Cancer Center Cancer Research and Development Fund
Institute
Department

Funding Source
Organization	National Cancer Center Cancer Research and Development Fund
Organization
Division
Category of Funding Organization	Other
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	YES
Study ID_1	2011-165
Org. issuing International ID_1	National Cancer Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立がん研究センター中央病院（東京都） National Cancer Center Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 17 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	Completed
Date of protocol fixation	2012 Year 02 Month 27 Day
Date of IRB	2012 Year 01 Month 01 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry	2019 Year 02 Month 01 Day
Date trial data considered complete
Date analysis concluded	2019 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2012 Year 07 Month 05 Day
Last modified on	2020 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008844