UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015413 |
|---|---|
| Receipt number | R000017927 |
| Scientific Title | Prospective study; Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT and 62Cu-ATSM PET/CT with reference to histopathology. |
| Date of disclosure of the study information | 2014/10/18 |
| Last modified on | 2015/09/15 18:07:07 |
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Basic information
Public title
Prospective study; Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT and 62Cu-ATSM PET/CT with reference to histopathology.
Acronym
Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT
Scientific Title
Prospective study; Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT and 62Cu-ATSM PET/CT with reference to histopathology.
Scientific Title:Acronym
Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical usefulness of FAZA and ATSM PET for patients with primary lung cancer who are scheduled to receive curative resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
The accumulation of FAZA and ATSM at the tumor
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 lung cancer either pathologically or cytologically.
2) The case who was scheduled to receive a curative resection.
3) The case to whom iodine contrast media can be injected.
4) The case who gave the written consent to join the study.
5) 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 | |
| Middle name | |
| Last name | Mitsutomo Kohno |
Organization
Department of Surgery, Keio University School of Medicine
Division name
General thoracic surgery
Zip code
Address
35 Shinanomachi Shinjuku
TEL
0353633806
kohno@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutomo Kohno |
Organization
Department of Surgery, Keio University School of Medicine
Division name
General thoracic surgery
Zip code
Address
35 Shinanomachi Shinjuku
TEL
0353633806
Homepage URL
kohno@a3.keio.jp
Sponsor or person
Institute
Division of General Thoracic Surgery, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Division of General Thoracic Surgery, School of Medicine, Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Functional Imaging Division, National Cancer Center Hospital East, Kashiwa, Japan
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The result of this trial will be presented in academic meeting and article.
Management information
Registered date
| 2014 | Year | 10 | Month | 11 | Day |
Last modified on
| 2015 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017927
