UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006466 |
|---|---|
| Receipt number | R000007670 |
| Scientific Title | Evaluation of molecular imaging of DNA synthesis for diagnosis, theraputic value and recurrent diagnosis of head and neck tumor |
| Date of disclosure of the study information | 2011/10/04 |
| Last modified on | 2011/10/04 13:23:23 |
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Basic information
Public title
Evaluation of molecular imaging of DNA synthesis for diagnosis, theraputic value and recurrent diagnosis of head and neck tumor
Acronym
4'-[methyl-11C]thiotymidine(4DST)PET for head and neck carcinoma diagnosis
Scientific Title
Evaluation of molecular imaging of DNA synthesis for diagnosis, theraputic value and recurrent diagnosis of head and neck tumor
Scientific Title:Acronym
4'-[methyl-11C]thiotymidine(4DST)PET for head and neck carcinoma diagnosis
Region
| Japan |
Condition
Condition
Head and neck carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of 4DST-PET for diagnosis of head and neck carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
As a surrogate marker of pretreatment and theraputic evaluation, 4DST-PET could be superior than FDG-PET.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age:>20 years old at entry of this traial
2.Pathological diagnosis was squamous cell carcinoma
3.Patient who was planning of chemoradiation in primary lesion.
4.Completed the written informed consent.
Key exclusion criteria
1.Pregnancy or lactating womem, or women with suspected pregnancy.
2.Patient with severe underlying disease having risk of liver dysfunction, renal dysfunction and any metabolic damage.
3.Just after surgery and/or trauma.
4.Poor controled diabetics.
5.Anaphylaxis of thiotymidine or tymidine.
6.Those who are determined as not appropriate for the study by physician in chief.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jyunkichi Yokoyama |
Organization
Juntendo university hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-3, Hongo, Bunkyoku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jyunkichi Yokoyama |
Organization
Juntendo university hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-3, Hongo, Bunkyoku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Juntendo university hospital
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
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 | 10 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compared with FDG uptake by tumor tissue and 4DST uptake by tumor tissue.
Management information
Registered date
| 2011 | Year | 10 | Month | 04 | Day |
Last modified on
| 2011 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007670
