UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004208 |
|---|---|
| Receipt number | R000005057 |
| Scientific Title | The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2010/09/15 |
| Last modified on | 2020/03/23 13:10:02 |
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Basic information
Public title
The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer
Acronym
FAZA PET/CT tests for patients with lung cancer
Scientific Title
The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer
Scientific Title:Acronym
FAZA PET/CT tests for patients with lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical usefulness of F-18 FAZA PET/CT for patients with primary non-small cell lung cancer who are scheduled to receive curative treatments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The accumulation of FAZA at the tumor
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
| Medicine |
Interventions/Control_1
F-18 FAZA 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The case who was diagnosed as primary non-small cell lung cancer either pathologically or cytologically.
2) The case whose primary lesion was no smaller than 1cm on CT images.
3) The case who was scheduled to receive a curative treatment such as surgery, radiation, chemotherapy and chemoradiotherapy.
4) The case to whom iodine contrast media can be injected.
5) The case who gave the written consent to join the study.
6) The case whose PS is between 0 and 2, the case who suffers from a serious illness except malignancy and the case who will become pregnant.
Key exclusion criteria
1) The case who is difficult to be included in the study due to psychological disorder and so on.
2) The case to whom the test agent cannot be injected due to iodine allergy and so on.
3) The case who is judged by the physician in charge not to be included in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | HIROFUMI |
| Middle name | |
| Last name | FUJII |
Organization
National Cancer Center Hospital East
Division name
Functional Imaging Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-6831
fujii-rad@umin.org
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Fujii |
Organization
National Cancer Center Hospital East
Division name
Functional Imaging Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-6831
Homepage URL
fujii-rad@umin.org
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
The Health and Labor Sciences Research Grants for Third Term Comprehensive 10-year Strategy for Cancer Control
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Research Ethics, National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
Tel
03-3542-2511
NCC@IRBofficeml.res.ncc.go.jp
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
| 2010 | Year | 09 | Month | 15 | 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
| 2010 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005057
