UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005128 |
|---|---|
| Receipt number | R000005621 |
| Scientific Title | Functional imaging for advanced cancer treatment |
| Date of disclosure of the study information | 2011/02/23 |
| Last modified on | 2016/09/01 09:21:04 |
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Basic information
Public title
Functional imaging for advanced cancer treatment
Acronym
FACT
Scientific Title
Functional imaging for advanced cancer treatment
Scientific Title:Acronym
FACT
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Urology |
| Radiology | Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the most appropriate diagnostic method to detect resistant tumor tissues in advanced cancer using PET probes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analyzing the correlation between PET tracer accumulation and effects of the treatment, such as radiotherapy and chemotherapy.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Functional PET imaging
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Advanced cancer
Key exclusion criteria
Patients who do not take any treatments.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidehiko Okazawa |
Organization
University of Fukui
Division name
Biomedical Imaging Research Center
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui, 910-1193 Japan
TEL
0776-61-8491
okazawa@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidehiko Okazawa |
Organization
University of Fukui
Division name
Biomedical Imaging Research Center
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui, 910-1193 Japan
TEL
0776-61-8491
Homepage URL
bircfukui@gmail.com
Sponsor or person
Institute
Biomedical Imaging Research Center, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2011 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0155635
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
Main results already published
Date of protocol fixation
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 23 | Day |
Last modified on
| 2016 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
