UMIN-CTR Clinical Trial

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
Institute	Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049071