UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022354
Receipt number R000025768
Scientific Title Usefulness of using C-11 methionine PET in patient which suspected glioma
Date of disclosure of the study information 2016/05/19
Last modified on 2019/05/22 17:49:07

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Basic information

Public title

Usefulness of using C-11 methionine PET in patient which suspected glioma

Acronym

Usefulness of using C-11 methionine PET in patient which suspected glioma

Scientific Title

Usefulness of using C-11 methionine PET in patient which suspected glioma

Scientific Title:Acronym

Usefulness of using C-11 methionine PET in patient which suspected glioma

Region

Japan


Condition

Condition

glioma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To obtain reliable datafor pharmaceutical approval application, we aim to test whether C-11 methionine PET has additional clinical value to MRI.
C-11 methione will be prepared using a methionine synthesizer(C-MET100).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive-predictive value (PPV) in the site of negative contrast-enhanced MRI and positive Met-PET which assume a histopathology diagnosis criteria diagnosis.

Key secondary outcomes

(1) Rate of cases where Met-PET positive area is equivalent to MRI enhanced area
(2)Rate of cases where tumor exists in the area of MRI-positive and Met-PET-negative findings.
(3)Safety:
Presence/absence and details of the adverse event, including abnormal changes of vital signs and laboratory data.


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

Device,equipment

Interventions/Control_1

Usefulness of using C-11 methionine PET

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

(1)The patients whose doctor plans a biopsy or tumor resection and whose tumor is suspected as primary glioma by board-certified diagnostic radiologists and board-certified neurosurgeons based on clinical manifestations, clinical courses, and MRI findings.
(2)The patients who or whose legal representative gave a written informed consent to this study.

Key exclusion criteria

(1)The patients with a history of allergic reaction to C-11 methionine or F-18 FDG.
(2)Pregnant women, breast-feeding women, or women who may be pregnant
(3)The patients who is participating in other trials
(4)The patients who underwent C-11 methionine PET within 90 days
(5)The patients whose overall status is not satisfactory for surgical treatment
(6) The patients who cannot undergo contrast-enhanced MRI
(7) The patients whom investigators judged to be inadequate as candidates

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Hatazawa

Organization

Osaka University Hospital

Division name

Department of Nuclear Medicine

Zip code


Address

2-15 Yamadaoka, Suita, Osaka

TEL

06-6879-3461

Email

hatazawa@tracer.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eku Shimosegawa

Organization

Osaka University Hospital

Division name

Department of Nuclear Medicine

Zip code


Address

2-15 Yamadaoka, Suita, Osaka

TEL

06-6879-3461

Homepage URL


Email

eku@mi.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

YES

Study ID_1

UMIN000022067

Org. issuing International ID_1

Hokkaido University Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立大学法人 大阪大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 19 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 06 Month 27 Day

Date of IRB

2019 Year 04 Month 11 Day

Anticipated trial start date

2017 Year 02 Month 06 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 19 Day

Last modified on

2019 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025768


Research Plan
Registered date File name
2018/11/20 HTC-MET-01_試験験実施計画書_第6.01版.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name