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临床试验/NCT05651360
NCT05651360已完成不适用

Diagnostic Performance of Deep Learning Image Reconstruction in Low Dose CT for the Detection of Acute Abdominal Conditions

Oslo University Hospital2 个研究点 分布在 2 个国家目标入组 246 人开始时间: 2022年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
246
试验地点
2
主要终点
Diagnostic performance of low-dose CT

研究概览

简要总结

The goal of this non-inferiority observational study is to assess the diagnostic performance of low-dose CT with deep learning image reconstruction (DLIR) in adult participants with acute abdominal conditions. The main research question is:

• Can low-dose CT with DLIR achieve the same diagnostic performance as standard CT for the diagnosis of acute abdominal conditions.

Participants will be examined with an additional low-dose CT directly after the standard CT. Participant will be their own controls.

Registration record updated on 15.05.2026 to correct entry errors (correction of sample size calculation now resulting in a larger sample size than previously stated, mixed-effects logistic regression was used for analysis of the diagnostic accuracy) so that the record reflects the study protocol in effect before enrollment of the first participant.

详细描述

Background Computed Tomography (CT) has become an essential tool in modern clinical medicine. With widespread availability, a rapid increase in the use of CT imaging has been observed over the last decades. With the associated increase in radiation exposure, the potential increased risk for radiation-induced malignancy has become a public health concern. This is especially true for CT scans of the abdomen and pelvis which currently account for 50% of the collective CT dose. As the benefit of dose reduction in general is offset by deterioration of image quality, technological advances to reduce radiation dose without compromising image quality are aspired in clinical practice.

In CT-image reconstruction, filtered back projection (FBP) has been the dominant image reconstruction technique algorithm since the early 1970s, complemented by the first commercial iterative reconstruction (IR) algorithms in 2009.

A novel deep learning image reconstruction (DLIR) algorithm received clinical approval in 2019 (TrueFidelity, GE Healthcare, Milwaukee, WI). Other vendor-specific algorithms for deep learning image reconstruction are also emerging (AiCE, Canon Medical Systems, Otawara, Japan). As explained by a technical white paper, having been trained with high-dose and low-dose FBP datasets across phantom and patient cases, the DLIR algorithm strives to suppress image noise without compromising image quality. The use of deep learning image reconstruction has demonstrated potential for improved image quality and dose reduction without shifting noise texture.

For patients with acute abdominal conditions, CT of the abdomen and pelvis is considered the best first- or second-line diagnostic approach. For these patients a fast and accurate diagnosis is of great importance to avoid treatment delay and subsequent complications such as gastrointestinal perforation in case of appendicitis or diverticulitis. On the other hand, it is also important to avoid unnecessary surgical intervention and the related complications. A possible low-dose CT protocol must therefore provide a non-inferior diagnostic performance to facilitate fast diagnosis and avoid overtreatment and inconclusive examinations.

Promising results have been reported regarding low-dose CT examinations with model-based IR and dose reduction of up to 75-80%. However, with the introduction of DLIR even further dose reduction seems feasible. Our own results from an image quality perception study with DLIR indicate that a dose reduction of up to 92.5% compared to standard CT might preserve acceptable diagnostic image quality (yet unpublished work).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients under evaluation for an acute abdominal condition who are referred to CT of the abdomen and pelvis.
  • Age >18 years
  • The patients must be able to give their oral and written consent to study participation.

排除标准

  • Contraindications regarding contrast enhanced CT examinations like known iodinated contrast media adverse reactions or claustrophobia.
  • Pregnancy.

研究组 & 干预措施

Abdominal Pain

Participants under evaluation for an acute abdominal condition who are referred to CT of the abdomen and pelvis.

干预措施: low-dose CT (Diagnostic Test)

结局指标

主要结局

Diagnostic performance of low-dose CT

时间窗: 4 to 6 months

Diagnostic performance of low-dose CT compared to standard CT according to ICD 10 diagnosis. Diagnostic performance measured in terms of: Sensitivity given in % according to TP/(TP+FN); specificity given in % according to TN/(TN+FP); positive predictive value given in % according to TP/(TP+FP); negative predictive value given in % according to TN/(TN+FN); accuracy given in % according to (TP+TN)/(TP+TN+FP+FN). Number true positive (TP); number true negative (TN); number false positive (FP); number false negative (FN).

次要结局

  • Image quality - noise(4 to 6 months)
  • Perceived image quality(4 to 6 months)
  • Radiation dose(4 to 6 months)
  • Diagnoses(4 to 6 months)
  • Image quality - contrast-to-noise ratio(4 to 6 months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anselm Schulz,MD

MD, PhD

Oslo University Hospital

研究点 (2)

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