jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

Mar. 08, 2019

May. 07, 2024

jRCTs052180103

Development and evaluation of chest functional examination technology with flat panel detector

Development of dynamic X-ray inspection technology

Mar. 21, 2024

378

378 subjects (270 males and 108 females) were included. Respiratory disease (obstructive pulmonary disease/interstitial lung disease, etc.), tumor diseases (lung tumor, etc.), and other diseases (cardiovascular disease, etc.) were 206, 156, and 16 cases, respectively.

The number of subjects was increased as the research progressed, and 378 cases who underwent dynamic radiography were included in the analysis.

Subjects' diseases, etc. (unfavorable changes in health (including abnormal laboratory test values), all serious adverse events, and deaths were not observed.

1. The analysis of thoracic cage movement (especially posterior ribs) using dynamic chest radiographs has the potential to predict the severity of chronic obstructive pulmonary disease (COPD) and the risk of exacerbation. [Details] Twenty COPD patients underwent dynamic chest radiography analysis and were compared with controls with normal pulmonary function. The COPD stage according to Japanese guidelines was stage1:stage2:stage3:stage4 = 3:8:4:5, and the breakdown of GOLD classification based on symptoms, lung function, and exacerbation frequency was A:B:C:D = 4:8:3:5. The results showed that the thoracic movements of patients with severe COPD were abnormal, especially the movements of the lower posterior ribs, which tended to synchronize with the movements of the upper and middle ribs, unlike in normal cases. In the severe cases, there was decreased ventilation in the upper lung field. 2. The analysis of pulmonary blood flow mapping images obtained from dynamic chest radiographs has confirmed the possibility of evaluating pulmonary circulatory impairment indicated by decreased pulmonary diffusion capacity. [Details] Twenty-six patients with normal pulmonary function and COPD without obvious interstitial changes were included in the study. Comparisons were made between the DLco>=70% group (control group: n=15) and DLco<70% (reduced group: n=11), with pulmonary diffusion capacity (DLco) = 70%/predicted value as the cut-off value. Maximum Intensity Projection (MIP) of pulmonary blood flow mapping images was used as the pulmonary blood flow evaluation method. Results showed that MIP in the reduced group (0.48 plus-minus 0.086) was lower (p<0.05) than that in the control group (0.59 plus-minus 0.133), confirming the difference.

The analysis of dynamic chest radiography (diaphragm and thorax movement, ventilation/ perfusion mapping images), which can be taken at the same cost, time, and exposure as the conventional initial X-ray examination, has confirmed the possibility of visually or partially quantitatively evaluating lung function and areas of impaired pulmonary ventilation/blood flow.

May. 06, 2024

Oct. 26, 2020

https://doi.org/10.1002/acm2.13071https://doi.org/10.1002/rcr2.737

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs052180103

Hasebe Terumitsu

Tokai University Hachioji Hospital

1838 Ishikawa-machi, Hachioji-shi, Tokyo, Japan

+81-42-639-1111

hasebe@tokai-u.jp

Hasebe Terumitsu

Tokai University Hachioji Hospital

1838 Ishikawa-machi, Hachioji-shi, Tokyo, Japan

+81-42-639-1111

hasebe@tokai-u.jp

Complete

Jan. 04, 2018

Jan. 04, 2018
410

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

The patient with respiratory diseases meets following conditions.
1. Patient visits or has been admitted in the pulmonary medicine or the pulmonary surgery in Tokai University Hachioji Hospital.
2. Patient is suspected of tumor or abnormality in respiration or perfusion.
3. Patient took/will take computed tomography or the lung function test.
4. Patient can take breathing at rest, forced breathing and hold breathing at stand position or supine position.
5. Patient agrees with this study.
The volunteer meets following conditions.
1. Volunteer can take breathing at rest, forced breathing and hold breathing at stand position or supine position.
2. Volunteer agrees with this study.

1. Pregnancy
2. Person whom investigator or subinvestigator recognize ineligible.

20age old over
No limit

Both

respiratory diseases

Dynamic imaging is performed for patients with respiratory diseases.

Correlation coefficient between comparison objects for diaphragm motion range and change amount of average pixel value in lung field.

The degree of agreement between ventilation/blood-flow mapping image and the gold standard.

KONICAMINOLTA,INC.
Not applicable
Certified Review Board, Shiga University of Medical Science
Seta Tsukinowa-cho, Otsu, Shiga

+81-77-548-3576

hqrec@belle.shiga-med.ac.jp
Approval

Feb. 12, 2019

none

History of Changes

No Publication date
10 May. 07, 2024 (this page) Changes
9 Mar. 09, 2023 Detail Changes
8 July. 15, 2022 Detail Changes
7 June. 13, 2022 Detail Changes
6 July. 09, 2021 Detail Changes
5 Mar. 11, 2021 Detail Changes
4 Aug. 20, 2020 Detail Changes
3 July. 10, 2020 Detail Changes
2 Jan. 17, 2020 Detail Changes
1 Mar. 08, 2019 Detail