UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032498
Receipt number R000037061
Scientific Title Assessment of amino-acid C-11 MeAIB-PET for oncologic imaging
Date of disclosure of the study information 2018/05/07
Last modified on 2019/05/13 11:41:04

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Basic information

Public title

Assessment of amino-acid C-11 MeAIB-PET for oncologic imaging

Acronym

Amino-acid C-11 MeAIB-PET imaging

Scientific Title

Assessment of amino-acid C-11 MeAIB-PET for oncologic imaging

Scientific Title:Acronym

Amino-acid C-11 MeAIB-PET imaging

Region

Japan


Condition

Condition

malignant tumors

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of amino acid C-11 MeAIB-PET imaging in patients with malignant tumors

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic accuracy

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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

IV injection of radiopharmaceutical agent (C-11 MeAIB) and radiation exposure, Imaging of 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who are diagnosed as having malignancy in clinical practice

Key exclusion criteria

patients who cannot stay calm in bed at the time of PET/CT imaging

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Chio
Middle name
Last name Okuyama

Organization

Shiga Medical Center Research Institute

Division name

Division of PET Imaging

Zip code

524-8524

Address

5-4-30, Moriyama, Moriyama-City, Shiga

TEL

077-582-6034

Email

okuyama@res.med.shiga-pref.jp


Public contact

Name of contact person

1st name Chio
Middle name
Last name Okuyama

Organization

Shiga Medical Center Research Institute

Division name

Division of PET Imaging

Zip code

524-8524

Address

5-4-30, Moriyama, Moriyama-City, Shiga

TEL

077-582-6034

Homepage URL


Email

okuyama@res.med.shiga-pref.jp


Sponsor or person

Institute

Shiga Medical Center Research Institute

Institute

Department

Personal name



Funding Source

Organization

Shiga Medical Center Research Institute

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga General Hospital

Address

5-4-30, Moriyama-cho, Moriyama. Shiga.524-8524, Japan

Tel

077-582-6034

Email

kenkyu@res.med.shiga-pref.jp


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

滋賀県立総合病院研究所


Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 07 Day


Related information

URL releasing protocol

http://www.shigamed.jp/

Publication of results

Published


Result

URL related to results and publications

http://www.shigamed.jp/

Number of participants that the trial has enrolled

200

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2013 Year 07 Month 04 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2008 Year 12 Month 01 Day

Date of IRB

2009 Year 03 Month 01 Day

Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 05 Month 13 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 07 Day

Last modified on

2019 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name