UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004319 |
|---|---|
| Receipt number | R000005176 |
| Scientific Title | Clinical pharmacological study of [11C]S-dThd reflecting DNA synthesis rate |
| Date of disclosure of the study information | 2010/10/04 |
| Last modified on | 2012/12/21 11:05:31 |
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Basic information
Public title
Clinical pharmacological study of [11C]S-dThd reflecting DNA synthesis rate
Acronym
Clinical pharmacological study of [11C]S-dThd
Scientific Title
Clinical pharmacological study of [11C]S-dThd reflecting DNA synthesis rate
Scientific Title:Acronym
Clinical pharmacological study of [11C]S-dThd
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety of [11C] S-dThd, to analyze the pharmacokinetics, to estimate the exposure dose, and to evaluate the tumor accumulation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, pharmacokinetics, exposure dose, and tumor accumulation
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 |
Interventions/Control_1
[11C] S-dThd 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Untreated cancer patients
Key exclusion criteria
- Severe heart disease (≥ NYHA class II)
- Severe renal dysfunction
- Performance Status (PS)≥2; intolerable to PET scanning
- Lack in ability to give an informed consent
- Patients regarded as unsuitable by responsible investigators
Target sample size
6
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
National Institute of Radiological Sciences
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
| 2010 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 03 | 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
| 2010 | Year | 10 | Month | 04 | Day |
Last modified on
| 2012 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005176
