UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT
Acronym	Diagnostic efficacy of 11C-methionine PET/CT for malignant tumors.
Scientific Title	Evaluation study of diagnostic efficacy in malignant tumors using 11C-methionine PET/CT
Scientific Title:Acronym	Diagnostic efficacy of 11C-methionine PET/CT for malignant tumors.
Region	Japan

Condition
Condition	Malignant tumor
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology Neurology Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate diagnostic efficacy of 11C- methionine PET/CT for malignant tumors of limited FDG PET efficacy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concordance with histological diagnosis of surgical specimen. Concordance of clinical stage with postsurgical stage.
Key secondary outcomes

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 Maneuver
Interventions/Control_1	11C-methionine PET/CT
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	Patients who meet all of the following conditions.1. Malignant tumor of either brain, mediastinum, lung, or urinary tract2. Surgery is planned 3. Medically fits for surgery4. Written informed consent obtained.
Key exclusion criteria	Patients who meet at least one of the following conditions.1. Malignant tumor of neiother brain, mediastinum, lung, nor urinary tract.2. Medically unfit for surgery or suegery not planned.3. Informed consent not given.
Target sample size	1500

Research contact person
Last name of lead principal investigator	1st name Ichiei Middle name Last name Kuji
Organization	Saitama Medical University
Division name	Saitama International Medical Center
Zip code	350-1298
Address	Yamane 1397-1, Hidaka-shi, Saitama
TEL	042-984-4147
Email	kuji@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Ichiei Middle name Last name Kuji
Organization	Saitama Medical University International Medical Center
Division name	Clinical Trial Support Center
Zip code	350-1298
Address	Yamane 1397-1, Hidaka-shi, Saitama
TEL	042-984-4523
Homepage URL
Email	chikens@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Radiology Saitama Medical Center Saitama Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Medical University International Medical Center IRB
Address	Yamane 1397-1, Hidaka-shi, Saitama
Tel	042-984-4523
Email	chikens@saitama-med.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	埼玉医科大学国際医療センター 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 06 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	1563
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	Terminated
Date of protocol fixation	2007 Year 07 Month 09 Day
Date of IRB	2007 Year 07 Month 18 Day
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2009 Year 06 Month 05 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002265