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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006466
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo university hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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