UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016369 |
|---|---|
| Receipt number | R000019012 |
| Scientific Title | Cu-62 ATSM PET/CT tests for thoracic an head and neck malignant tumors |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2021/08/04 09:44:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cu-62 ATSM PET/CT tests for thoracic an head and neck malignant tumors
Acronym
ATSM PET for thoracic and H&N tumors
Scientific Title
Cu-62 ATSM PET/CT tests for thoracic an head and neck malignant tumors
Scientific Title:Acronym
ATSM PET for thoracic and H&N tumors
Region
| Japan |
Condition
Condition
thoracic malignalt tumors
head and neck malignant tumors
Classification by specialty
| Pneumology | Chest surgery | Oto-rhino-laryngology |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of ATSM PET/CT tests for thoracic and head and neck malignant tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
index for tumor uptake of ATSM
CT number in tumors on ATSM PET/CT test
Therapeutic effects
Date of reccurence and/or death
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
ATSM PET/CT test
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) thoracic and head and neck malignant tumors diagnosed histopathologically or clinically
2) radiotherapy or chemoradiotherapy is considered at NationalCancer Center East
3) tolerable for PET/CT tests (PS 0-1)
4) written informed concent is obtained
Key exclusion criteria
Cases judged unsuitable by medical doctors
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Fujii |
Organization
National Cancer Center Hospital East
Division name
Division of Functional Imaging
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-6832
hifujii@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Fujii |
Organization
National Cancer Center Hospital East
Division name
Division of Functional Imaging
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa
TEL
04-7134-6832
Homepage URL
hifujii@east.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)
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
| 2015 | Year | 02 | Month | 01 | 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
| 2015 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 02 | 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
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019012
