臨床研究等提出・公開システム

Examination of the usefulness of pulmonary ventilation and circulatory disorder evaluation technology using a dynamic flat-panel detector system for patients with pulmonary hypertension

Evaluation of pulmonary ventilation and circulatory disorder by a dynamic flat-panel detector system

21

A total of 21 subjects were finally enrolled in this study. The 21 patients had an average age of 58 years, 15 of whom were female. In addition, one of the above 21 subjects was excluded from the maximum analysis target population, so the final analysis was performed on 20 subjects.

This study collected and enrolled subjects from the implementation plan publication date in 2020 to September 30, 2021. The initial target number of cases was 50, but due to the impact of the COVID-19 pandemic, the final number of registered patients was 21.In addition, the design of this study included a follow-up period after treatment in addition to a pre-treatment period. However, due to the reasons mentioned above, only 2 cases were finally able to complete the follow-up period, and 19 cases were discontinued during the study.

There were no disease outbreaks attributable to the conduct of the study and no subjects were eligible for compensation during the study period. On the other hand, two subjects developed diseases for which a causal relationship was not recognized in this study. Specifically, one patient developed B-cell non-Hodgkin's lymphoma and one patient developed hepatocellular carcinoma during the study period.

Concerning the primary endpoint, although a certain degree of agreement was observed for pulmonary perfusion and ventilation deficits in the right lower lung field, the agreement was generally low for evaluation in all lung fields. On the other hand, the evaluation of pulmonary ventilation/perfusion mismatch showed reasonable agreement regardless of the location of the lung field. Regarding the secondary endpoints, the sensitivity of detection of pulmonary perfusion defect and pulmonary ventilation-perfusion mismatch was particularly good, while the detection of pulmonary ventilation defect had low sensitivity but good specificity.Due to lack of post-treatment data, we did not analyze the usefulness for confirming the treatment effect. Also, there were no related adverse events.

Taken together, these results suggest that low-dose dynamic chest X-ray imaging may be useful in some situations in the diagnosis and treatment of pulmonary hypertension.

April. 30, 2023

No

N/A

https://jrct.niph.go.jp/latest-detail/jRCTs032200102

Sakao Seiichiro

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba-city Chiba, Japan

sakaos@faculty.chiba-u.jp

Sakao Seiichiro

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba-city Chiba, Japan

+81-432227171

sakaos@faculty.chiba-u.jp

Complete

Aug. 31, 2020

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1. Patients suspected with pulmonary hypertension (PH) or patients diagnosed with PH who start medical or surgical treatment
2. Patients aged 20 to 75 at the time of obtaining consent
3. Patients with or expected to have a ventilation/perfusion scintigram test
4. Patients who can perform forced breathing, quiet breathing, and breath-hold in the standing or lying position
5. Written informed consent

1. Ventilation/perfusion scintigram maladjusted patients
2. Pregnant and/or lactating women
3. Patients judged to be ineligible

Both

Pulmonary hypertension

Conducting X-ray dynamic image inspection by a dynamic flat-panel detector system

PH Ventilation Perfusion

Ability to detect pulmonary ventilation and perfusion defects

Effectiveness for confirming therapeutic effect, ability to express quantitative values of pulmonary ventilation and perfusion

+81-43-226-2616

None