UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005436 |
|---|---|
| Receipt number | R000006451 |
| Scientific Title | Evaluation of 62Cu-ATSM PET/CT in carbon ion  radiotherapy to refractory cancer |
| Date of disclosure of the study information | 2011/04/13 |
| Last modified on | 2012/12/26 08:40:34 |
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Basic information
Public title
Evaluation of 62Cu-ATSM PET/CT in carbon ion  radiotherapy to refractory cancer
Acronym
ATSM clinical study for refractory cancer 1
Scientific Title
Evaluation of 62Cu-ATSM PET/CT in carbon ion  radiotherapy to refractory cancer
Scientific Title:Acronym
ATSM clinical study for refractory cancer 1
Region
| Japan |
Condition
Condition
Lung cancer, Head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between the accumulation of the hypoxia probe 62Cu-ATSM and the outcome of carbon ion radiotherapy or the intractable region in refractory cancer, through 62Cu-ATSM hypoxia PET/CT imaging in cancer patients planned for carbon ion radiotherapy at NIRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative and semi-quantitative assessment of tumor uptake on 62Cu-ATSM and FDG PET images.
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
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
62Cu-ATSM and 18FDG 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
Lung cancer and head and neck cancer patients planned for carbon ion radiotherapy at NIRS
Key exclusion criteria
Patients regarded as unsuitable by principle investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneo Saga |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa Inage, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa Inage, Chiba
TEL
Homepage URL
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
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
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 | 04 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 05 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 05 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 13 | Day |
Last modified on
| 2012 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006451
