UMIN-CTR Clinical Trial

Basic information
Public title	Quantitative assessment of pulmonary blood flow in control subjects, subjects with chronic obstructive lung disease (COPD), or with pulmonary hypertension (PH) by 15O-H2O PET/CT
Acronym	Quantitative assessment of pulmonary blood flow by 15O-H2O PET/CT
Scientific Title	Quantitative assessment of pulmonary blood flow in control subjects, subjects with chronic obstructive lung disease (COPD), or with pulmonary hypertension (PH) by 15O-H2O PET/CT
Scientific Title:Acronym	Quantitative assessment of pulmonary blood flow by 15O-H2O PET/CT
Region	Japan

Condition
Condition	COPD, PH
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To assess and compare the pulmonary or myocardial blood flow and their heterogeneity of those flow in control subjects, patients with COPD, and in patients with PH.2.To compare the pulmonary blood flow assessed by 15O-H2O PET/CT and the diffusion capacity of carbon monoxide or transfer coefficient of the lung.in control subjects, patients with COPD, or with PH.Also in patient with PH, to compare the pulmonary blood flow assessed by 15O-H2O PET/CT and parameters of right heart catheterization, cardiac MRI,and Tc-MAA perfusion scintigraphy.3.To examine the pulmonary and myocardial flow reserve of blood flow in control subjects, patients with COPD, and patients with PH.4. To compare the pulmonary blood flow assessed by 15O-H2O PET/CT and the results of pulmonary function tests and scores of COPD activity test in patients with COPD. Particularly, to examine the relationships between quantity of the pulmonary blood flow assessed by 15O-H2O PET/CT and the severity of emphysema assessed by CT.
Basic objectives2	Others
Basic objectives -Others	Quantitative assessment of pulmonary blood flow by 15O-H2O PET/CT
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Pulmonary blood flow corrected by lung volume
Key secondary outcomes	Heterogeniety of pulmonary blood flow Flow reserve of pulmonary blood flow Myocardial blood flow at rest and during exercise Lung attenuation volume pulmonary function test:FEV1,FEV1FVC,DLco,DLcoVA COPD assessment test scoreEchocardiography: LV/LA diameter/area/volume,EF,cardiac output, cardiac index,LV eccentricity index, tricuspid regurgitation velocity, tricuspid annulus movement distance, Tei index, IVC diameter cardio pulmonary exercise test peak VO2, AT, VE/VCO2, stress level at AT, HR, RER, VE, VD/VT cardiac MRI: LV/RV/LA/RA volume/index, cardiac output/index, stroke volume, ventricular wall thickness/volume/index, Pulmonary circulation time, existence and volume of late enhancementRight heart catheterization: pulmonary arterial pressure, pulmonary arterial wedge pressure, RV/RA pressure, CO,CI, PVR, venous oxygen saturation ,Qr/Qs Tc-MAA perfusion scintigraphy defect of perfusion in the lung, ventilation and perfusion mismatch, the ratio of the right lung perfusion to the left lung perfusion, shunt ratio

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	Prevention
Type of intervention	Other
Interventions/Control_1	15O-H2O 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Control subjects:Subjects without any respiratory or cardiac or other disorders that might affect pulmonary blood volume COPD: Subjects with COPD who regularly visit Hokkaido university hospital.PH: Subjects who have the diagnosis of PH or are suspected of PH and regularly visit Hokkaido university hospital
Key exclusion criteria	1.Subjects who had participated in other clinical trials within the past one month. 2.Subjects who will not follow the study protocol. 3.Subjects who are pregnant or who are during the lactating period and who are suspected of pregnancy. 4.Subjects who do not agree with contraception during the study. 5. Subjects who principal investigators or members of this research consider not to be suitable for this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kaoruko Shimizu
Organization	Hokkaido University Hospital
Division name	First department of medicine
Zip code
Address	North 15 West 7, Kita-ku, Sapporo
TEL	011-706-5911
Email	kaorukoshimizu@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kaoruko Shimizu
Organization	Hokkaido Univertisy Hospital
Division name	First department of medicine
Zip code
Address	North 15 West 7, Kita-ku, Sapporo
TEL	011-706-5911
Homepage URL
Email	kaorukoshimizu@pop.med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 19 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
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	Completed
Date of protocol fixation	2017 Year 12 Month 28 Day
Date of IRB	2018 Year 01 Month 22 Day
Anticipated trial start date	2018 Year 01 Month 24 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 15 Day
Last modified on	2019 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034956

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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