UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042984
Receipt number R000049071
Scientific Title Diagnostic accuracy of intracranial lesion using 11C-Methionine PET/CT
Date of disclosure of the study information 2021/01/13
Last modified on 2022/10/31 09:46:25

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Basic information

Public title

Diagnostic accuracy of intracranial lesion using 11C-Methionine PET/CT

Acronym

Diagnostic accuracy using METPET/CT for intracranial lesion

Scientific Title

Diagnostic accuracy of intracranial lesion using 11C-Methionine PET/CT

Scientific Title:Acronym

Diagnostic accuracy using METPET/CT for intracranial lesion

Region

Japan


Condition

Condition

Brain tumor

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the final diagnosis and pre-treatment radiological diagnosis of 11C-Methionine PET/CT in multicenter retrospective study

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Final diagnosis

Key secondary outcomes

Maximum diameter, Shape, Lesion/normal ratio, Number, Area


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

The subjects who were taken 11C-Methionine PET/CT before treatment between April 1, 2017 and August 31, 2020. The final clinical diagnosis is mandatory.

Key exclusion criteria

1.Subjects who have no final clinical diagnosis.
2.Subjects who cannot provide informed consent.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Higuchi

Organization

Chiba University Graduate School of Medicine

Division name

Department of Neurological Surgery

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan

TEL

043-226-2158

Email

yhiguchi@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Yamaki

Organization

Rehabilitation Center for Traumatic Apallics Chiba

Division name

Neurosurgery & PET imaging division

Zip code

261-0012

Address

3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan

TEL

043-277-0061

Homepage URL


Email

t-yamaki@chiba-ryougo.jp


Sponsor or person

Institute

Rehabilitation Center for Traumatic Apallics Chiba

Institute

Department

Personal name



Funding Source

Organization

Rehabilitation Center for Traumatic Apallics Chiba

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Rehabilitation Center for Traumatic Apallics Chiba

Address

3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan

Tel

043-277-0061

Email

takahito-seki@chiba-ryougo.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

2021 Year 01 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.clinicalimaging.org/article/S0899-7071(22)00263-7/fulltext

Number of participants that the trial has enrolled

425

Results

Based on the ROC analyses, the cutoffs were 3.33 for maximum SUV, 2.54 for mean SUV, 2.33 for peak SUV, 2.04 for Lmax/Nmean, and 2.23 for Lmax/Nmax. The sensitivity and specificity of these cutoffs were 69.2% and 82.6%, respectively, for maximum SUV, 64.1% and 91.3% for mean SUV, 69.2% and 91.3% for peak SUV, 70.5% and 91.3% for Lmax/Nmax and 75.6% and 82.6% for Lmax/Nmean.

Results date posted

2022 Year 10 Month 31 Day

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

2020 Year 12 Month 16 Day

Date of IRB

2020 Year 12 Month 16 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2023 Year 12 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study


Management information

Registered date

2021 Year 01 Month 13 Day

Last modified on

2022 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name