UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030821
Receipt number R000034956
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
Date of disclosure of the study information 2018/01/19
Last modified on 2019/07/25 12:12:43

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Hokkaido University

Institute

Department

Personal name



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

Value
https://center6.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