UMIN-CTR Clinical Trial

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 (&#8805; NYHA class II) - Severe renal dysfunction - Performance Status (PS)&#8805;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
Email

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
Email

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005176

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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