UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020945
Receipt number R000024168
Scientific Title Prospective investigation of C-11 methionine PET/CT for bone tumor
Date of disclosure of the study information 2016/04/01
Last modified on 2018/03/26 20:15:01

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Basic information

Public title

Prospective investigation of C-11
methionine PET/CT for bone tumor

Acronym

Prospective investigation of C-11
methionine PET/CT for bone tumor

Scientific Title

Prospective investigation of C-11
methionine PET/CT for bone tumor

Scientific Title:Acronym

Prospective investigation of C-11
methionine PET/CT for bone tumor

Region

Japan


Condition

Condition

Bone tumor

Classification by specialty

Orthopedics Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this prospective study is
to assess the amino acid metabolism in bone tumor and internal organs
with C-11 methionine PET/CT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The correlation between C-11 methionine
uptake to the bone tumor and histological findings.

Key secondary outcomes

The comparison between C-11
methionine PET/CT and other imaging
modalities in patients with bone tumor.
The assessment of the C-11 methionine
uptake to internal organs with multiple-time-point PET/CT.


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

Preoperative examination of C-11
methionine PET/CT(C-11 methionine 3.7MBq/kg)(until March 31, 2022)

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

3 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients with suspected bone tumor who are to be operated.

Key exclusion criteria

Baby and toddler (under 3 years olds).
Pregnant female.
Nursing woman.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Harada

Organization

Tokushima university hospital

Division name

Department of Radiology

Zip code


Address

Kuramotocho 2-50-1, Tokushima-city

TEL

088-633-7173

Email

shinya.takayoshi@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoichi Otomi

Organization

Tokushima university hospital

Division name

Department of Radiology

Zip code


Address

Kuramotocho 2-50-1, Tokushima-city

TEL

088-633-7173

Homepage URL


Email

otomi.yoichi@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima university hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

徳島大学病院(徳島県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 01 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

Completed

Date of protocol fixation

2016 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 31 Day

Last follow-up date


Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 08 Day

Last modified on

2018 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name