UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the usefulness of [11C]4DST-PET/CT and [18F]FDG-PET/CT in the characterization of lung tumor
Title of the study (Brief title)	[11C]4DST-PET/CT clinical study for lung tumor
Region	Japan

Condition
Condition	lung tumor
Classification by specialty	Chest surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the usefulness of PET/CT using a cellular proliferation probe, [11C]4DST, and a glucose metabolism probe, [18F]FDG, in the characterization of lung tumors, both PET/CT examinations are performed for pre-surgical patients with lung tumors. The role of [11C]4DST and [18F]FDG as a prognostic indicator will be also evaluated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Tumor uptake of [11C]4DST and [18F]FDG Pathological characterization of resected tumors
Key secondary outcomes	Prognostic information of patients

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
Interventions/Control_1	[11C]4DST- and [18F]-FDG-PET/CT examinations
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	Lung tumor patients going to be operated with the suspicion of lung cancer
Key exclusion criteria	Patients regarded as unsuitable by responsible investigators
Target sample size	40

Research contact person
Name of lead principal investigator	Tsuneo Saga
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3421
Email	saga@nirs.go.jp

Public contact
Name of contact person	Tsuneo Saga
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-3421
Homepage URL
Email	saga@nirs.go.jp

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization	National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 09 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 07 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 18 Day
Last modified on	2018 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013784