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
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
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
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
