- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07575503
Diagnostic Value of Photon-Counting CT in Subsegmental Pulmonary Embolism
Application of Photon-Counting Computed Tomography in the Diagnosis of Subsegmental Pulmonary Embolism
Pulmonary embolism (PE) is a serious and potentially life-threatening condition caused by blood clots in the lungs. A particular type, subsegmental pulmonary embolism (SSPE), involves very small branches of the pulmonary arteries. Although these clots occur in smaller vessels, their risk of recurrence and complications may be similar to larger clots.
Conventional CT pulmonary angiography (CTPA) is the standard imaging test for suspected PE, but image quality can sometimes be limited by motion artifacts, poor contrast filling, or body habitus, making the detection of SSPE challenging.
Photon-counting computed tomography (PCCT) is a new CT technology that provides higher image resolution, lower radiation dose, and improved visualization of small blood vessels. Early studies suggest PCCT may reduce motion artifacts and increase the accuracy of detecting SSPE compared with conventional CT.
This prospective cohort study will compare PCCT with dual-source CT in patients with suspected acute PE. The study aims to determine whether PCCT improves the detection rate and image quality for SSPE, and whether it can provide more reliable diagnostic information to guide clinical care.
연구 개요
상세 설명
Pulmonary embolism (PE) is a leading cause of morbidity and mortality worldwide. Subsegmental pulmonary embolism (SSPE), defined as thrombi confined to subsegmental pulmonary arteries, may account for up to 20% of acute PE cases detected by multidetector CT. While distal in location, SSPE carries a risk of recurrent venous thromboembolism and mortality that is comparable to more proximal PE, suggesting that SSPE is not a benign entity. Accurate diagnosis is therefore clinically important, but remains challenging due to motion artifacts, poor contrast opacification, and the large number of small subsegmental vessels that must be evaluated.
Photon-counting computed tomography (PCCT) is a recently developed imaging technology that offers significant improvements over conventional energy-integrating detector CT (EID-CT). PCCT provides higher spatial resolution, direct spectral information, and the ability to generate virtual monoenergetic images and iodine maps in a single acquisition, while reducing radiation dose. Preliminary studies indicate that PCCT can minimize motion artifacts, improve image quality, and enhance visualization of small pulmonary arteries, potentially increasing the detection of SSPE.
This prospective observational cohort study will compare the diagnostic performance of PCCT with dual-source CT in patients with suspected acute PE. The primary outcome is the detection rate of SSPE. Secondary outcomes include image quality scores, radiation dose, and the added diagnostic value of PCCT in patients with negative findings on dual-source CT. By systematically evaluating image quality, detection yield, and radiation exposure, this study seeks to establish the potential role of PCCT as a superior diagnostic tool for SSPE in real-world clinical practice.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- 모병
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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연락하다:
- min Yan, doctor
- 전화번호: +86 13757118632
- 이메일: zryanmin@zju.edu.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥ 18 years
Clinical manifestations supporting the diagnosis of acute pulmonary embolism, including:
Acute onset or progressive dyspnea Unexplained hypoxemia Chest pain Hemoptysis Syncope or presyncope Combined with abnormal findings on electrocardiogram, echocardiography, or pulse oximetry
- Revised simplified Geneva score ≥ 3
- Written informed consent obtained from the patient or the patient's legally authorized representative
Exclusion Criteria:
- Patients requiring prophylactic or therapeutic doses of anticoagulant medication for reasons other than venous thromboembolism (VTE).
- Life expectancy less than three months.
- Patients unable to undergo CT scanning due to severe condition or hemodynamic instability.
- History of allergy to contrast media, renal insufficiency (creatinine clearance < 30 mL/min), or ongoing long-term dialysis.
- Pregnancy.
- Refusal to provide informed consent or inability to complete follow-up for any reason.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Group 1Title: Conventional CT group
Description: Patients with suspected pulmonary embolism who undergo dual-source or energy-integrating detector CT pulmonary angiography (EID-CTPA).
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Group 2 Title: Photon-counting CT group
Description: Patients with suspected pulmonary embolism who undergo photon-counting computed tomography (PCCT) for diagnosis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Detection rate of subsegmental pulmonary embolism (SSPE) using photon-counting CT versus dual-energy CT
기간: perioperative period
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The proportion of patients with suspected acute pulmonary embolism in whom SSPE is detected on photon-counting CT compared with dual-energy CT.
All scans will be independently assessed by two blinded radiologists to determine diagnostic yield.
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perioperative period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective image quality scores for SSPE diagnosis
기간: perioperative period
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ignal-to-Noise Ratio (SNR) and Contrast-to-Noise Ratio (CNR) will be calculated based on CT attenuation and image noise measured in standardized Regions of Interest (ROIs) within pulmonary vessels, the aorta, and paraspinal muscles.
Higher SNR and CNR values indicate better objective image quality.
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perioperative period
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Subjective image quality scores for SSPE diagnosis
기간: perioperative period
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Radiologists will qualitatively assess image noise and motion artifacts using a 5-point Likert scale (1 = Unacceptable, 5 = Excellent).
The average score of the readers will be used, with higher scores indicating better subjective image quality
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perioperative period
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Incidence of Venous Thromboembolism (VTE)
기간: 3 months
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Occurrence of symptomatic VTE, defined as Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE), confirmed by objective imaging upon clinical suspicion
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3 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-1248
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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Subsegmental Pulmonary Embolism에 대한 임상 시험
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University of Colorado, Denver모집하지 않고 적극적으로단심실 | 폐 혈관 저항 이상 | 대사체학 | 우수한 Cavo-Pulmonary 문합 | 엔도텔린미국