PloS one · 2026
Facilitating early diagnosis of chronic thromboembolic pulmonary hypertension with dynamic chest radiography: Protocol for a multicenter, assessor-blinded, case-wise randomized superiority reader study (FIND-DCR).
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Hosokawa Kazuya, Yamasaki Yuzo, Kishimoto Junji, Nagayama Tomomi, Adachi Shiro, Naganawa Shinji, Inami Takumi, Yokoyama Kenichi, Yasuda Satoshi, Takase Kei, Kubota Kayoko, Yoshiura Takashi, Sugiura Toshihiko, Uno Takashi, Kataoka Masaharu, Aoki Takatoshi, Usui Soichiro, Kobayashi Satoshi, Taniguchi Yu, Murakami Takamichi, Tamura Yuichi, Fukumoto Yoshihiro, Ishigami Kousei, Abe Kohtaro
Аннотация
INTRODUCTION: Chronic thromboembolic pulmonary hypertension (CTEPH) is a treatable cause of pulmonary hypertension but remains under-recognized and is often diagnosed with delay. Limited access to lung ventilation-perfusion (V/Q) scintigraphy, especially outside tertiary centers, is one contributor. Dynamic chest radiography (DCR), with a pulmonary circulation analysis program, can provide a rapid, non-invasive, and widely deployable assessment of pulmonary perfusion. We describe the protocol of a multicenter reader study testing whether adding DCR-based analysis to standard initial work-up improves diagnostic accuracy for CTEPH among patients with echocardiographically suspected pulmonary hypertension.
METHODS AND ANALYSIS: This investigator-initiated, multicenter, assessor-blinded, case-wise randomized superiority reader study compares standard initial work-up (blood tests, chest X-ray, ECG, pulmonary function tests, and transthoracic echocardiography per guidelines) with standard work-up plus DCR-based pulmonary circulation analysis. The primary endpoint is diagnostic accuracy for discrimination between CTEPH and non-CTEPH in the intention-to-treat set. The final diagnosis of CTEPH versus non-CTEPH will be defined as the reference standard according to the Japanese and European guidelines for pulmonary hypertension. Secondary endpoints include sensitivity, specificity, positive and negative predictive values; agreement with V/Q scintigraphy regarding regional perfusion defects using κ statistics; and STARD-conformant academic performance evaluation of DCR-based pulmonary circulation analysis and lung perfusion scintigraphy in relation to the site-level final diagnosis of CTEPH versus non-CTEPH in a full analysis set. Safety endpoints include adverse events during DCR acquisition and device malfunctions. The target sample size is 108 cases with 1:1 allocation. Recruitment started on 30/07/2025 and is expected to continue until 28/02/2027, with overall study completion planned for 31/05/2027.
DISCUSSION: This multicenter reader study addresses a key limitation of current CTEPH diagnostic pathways-reliance on V/Q scintigraphy, which may be delayed or unavailable outside tertiary centers-by evaluating whether DCR-based pulmonary circulation analysis can improve early discrimination of CTEPH and support timely referral.
TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT), jRCT2072250027.
METHODS AND ANALYSIS: This investigator-initiated, multicenter, assessor-blinded, case-wise randomized superiority reader study compares standard initial work-up (blood tests, chest X-ray, ECG, pulmonary function tests, and transthoracic echocardiography per guidelines) with standard work-up plus DCR-based pulmonary circulation analysis. The primary endpoint is diagnostic accuracy for discrimination between CTEPH and non-CTEPH in the intention-to-treat set. The final diagnosis of CTEPH versus non-CTEPH will be defined as the reference standard according to the Japanese and European guidelines for pulmonary hypertension. Secondary endpoints include sensitivity, specificity, positive and negative predictive values; agreement with V/Q scintigraphy regarding regional perfusion defects using κ statistics; and STARD-conformant academic performance evaluation of DCR-based pulmonary circulation analysis and lung perfusion scintigraphy in relation to the site-level final diagnosis of CTEPH versus non-CTEPH in a full analysis set. Safety endpoints include adverse events during DCR acquisition and device malfunctions. The target sample size is 108 cases with 1:1 allocation. Recruitment started on 30/07/2025 and is expected to continue until 28/02/2027, with overall study completion planned for 31/05/2027.
DISCUSSION: This multicenter reader study addresses a key limitation of current CTEPH diagnostic pathways-reliance on V/Q scintigraphy, which may be delayed or unavailable outside tertiary centers-by evaluating whether DCR-based pulmonary circulation analysis can improve early discrimination of CTEPH and support timely referral.
TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT), jRCT2072250027.