UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008359 |
|---|---|
| Receipt number | R000008844 |
| Scientific Title | Exploratory Study of Usefulness of 18F-BPA PET/CT in Clinical Staging of Malignancies |
| Date of disclosure of the study information | 2012/07/17 |
| Last modified on | 2020/01/10 12:27:35 |
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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
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
jitami@ncc.go.jp
Sponsor or person
Institute
"Hotta Group" of National Cancer Center Cancer Research and Development Fund
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008844
