UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005616 |
|---|---|
| Receipt number | R000006636 |
| Scientific Title | The usefulness of Cu-62 ATSM PET/CT to evaluate the sensitivity to radiotherapy for lung cancer and head and neck cancer |
| Date of disclosure of the study information | 2011/05/19 |
| Last modified on | 2020/11/23 18:06:32 |
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Basic information
Public title
The usefulness of Cu-62 ATSM PET/CT to evaluate the sensitivity to radiotherapy for lung cancer and head and neck cancer
Acronym
The evaluation of the sensitivity to radiotherapy by Cu-62 ATSM PET/CT
Scientific Title
The usefulness of Cu-62 ATSM PET/CT to evaluate the sensitivity to radiotherapy for lung cancer and head and neck cancer
Scientific Title:Acronym
The evaluation of the sensitivity to radiotherapy by Cu-62 ATSM PET/CT
Region
| Japan |
Condition
Condition
Lung cancer and head and neck cancer
Classification by specialty
| Pneumology | Chest surgery | Oto-rhino-laryngology |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of Cu-62 ATSM PET/CT to predict the sensitivity to radiotherapy for lung cancer and head and neck cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accumulation of Cu-62 ATSM in 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
Cu-62 ATSM 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)non-small cell lung cancer or head and neck cancer (pathologically or cytologically proven)
2)Radiotherapy or chemoradiotherapy is scheduled.
3)Iodine contrast media can be administered
4)Written informed concent was obtained.
5)PS 0-2, no severe complication besides malignancy, no pregnancy
6)AST ULNx2.5, ALT ULNx2.5, T.bil 2.0mg/dl, Serum creatinine 1.5mg/dl
Key exclusion criteria
1) Patient under the psychological condition
2) Patient to whom imaging agents cannot be injected
3) Patient who was judged as unsuitable by the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Fujii |
Organization
National Cancer Center
Division name
Division of Functional Imaging
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
Division name
Division of Functional Imaging
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-6831
Homepage URL
hifujii@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
MHLW
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 EXT. 2597
NCC_IRBoffice@ml.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
| 2011 | Year | 05 | Month | 19 | 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
47
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2008 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 17 | Day |
Last modified on
| 2020 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006636
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
