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

* 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

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 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


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

Value
https://center6.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