UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020581
Receipt number R000023760
Scientific Title Utility of 11C-Methionine PET in assessing malignancy of tumors
Date of disclosure of the study information 2016/01/16
Last modified on 2021/07/20 21:41:13

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Basic information

Public title

Utility of 11C-Methionine PET in assessing malignancy of tumors

Acronym

Utility of 11C-Methionine PET in assessing malignancy of tumors

Scientific Title

Utility of 11C-Methionine PET in assessing malignancy of tumors

Scientific Title:Acronym

Utility of 11C-Methionine PET in assessing malignancy of tumors

Region

Japan


Condition

Condition

Brain tumor, Head and neck cancer, lung cancer, soft tissue tumor, pancreas cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Pneumology Oto-rhino-laryngology
Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical utility of 11C-Methionine PET in characterization and grading of various tumors.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Methionine uptake in tumors (visual assessment, SUV quantification, uptake count)

Key secondary outcomes

1) histological malignancy
2) FDG uptake in tumors
3) ADC measurements by diffusion-weighted MRI


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

11C-Methionine

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

10 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have malignant tumors or are suspected to have malignant tumors.
Target disease: brain tumors, head and neck tumors, lung cancer, soft tissue tumor, pancreas cancer
Patients who agree and write informed consent form
Age >10 year-old
If subjects are child, their parent or guardian write informed consent form

Key exclusion criteria

Pregnancy
Claustrophobia
Patient who can not keep still during the examination Performance Status >3
Patients who are not informed to have malignancy, if applicable
MRI contradiction
1 Heart pacemaker
2 artificial ear
3 artificial hear valve
4 clip for cerebral aneurysm
5 artificial denture/implant
6 tattoo
7 other metals

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Honda

Organization

Kyushu University Hospital

Division name

Radiology

Zip code

812-8582

Address

3-1-1 Maidashi Higashiku, Fukuoka

TEL

092-642-5695

Email

honda@radiol.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Togao

Organization

Kyushu University Hospital

Division name

Radiology

Zip code

812-8582

Address

3-1-1 Maidashi Higashiku, Fukuoka

TEL

092-642-5695

Homepage URL


Email

togao@radiol.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University Hospital, Department of Clinical Radiology

Institute

Department

Personal name



Funding Source

Organization

Kyushu University Hospital, Department of Clinical Radiology

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

Clinical Radiology, Kyushu University

Address

3-1-1 Maidashi Higashiku Fukuoka Japan

Tel

092-642-5695

Email

togao.osamu.595@m.kyushu-u.ac.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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 16 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

Preinitiation

Date of protocol fixation

2015 Year 06 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 15 Day

Last modified on

2021 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023760


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name