Evaluation of C-arm Photon Counting Detector Cone Beam CT (PCD-CBCT) for Image-Guided Interventions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Confidence Score for Calcifications
研究概览
简要总结
The overarching objective of the project is to develop a new C-arm interventional x-ray imaging platform that integrates both a photon counting detector and a flat panel detector to provide high image quality and quantitative spectral computed tomography (CT) image guidance will be developed to enable more accurate and safe interventional procedures for patients.
详细描述
The objective of this pilot study is to assess the feasibility of acquiring high-quality images using new imaging concepts and methods. All imaging will be performed in addition to standard-of-care procedures and will not influence clinical decisions or patient management.
The endpoint of this project includes: 1) PCD-CBCT data will be processed to generate virtual non-iodine images for evaluating contrast extravasation, as well as virtual monoenergetic (VME) images. 2) Images will be analyzed retrospectively to evaluate image quality and explore potential clinical benefits of PCD-CBCT compared to flat panel detector cone beam CT (FPD-CBCT) and multidetector computed tomography (MDCT).
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
- 否
入选标准
- •Not pregnant or breastfeeding
- •Scheduled to receive image-guided intervention (IGI) of the head or the body
- •Pre-treatment multidetector computed tomography (MDCT) images available
排除标准
- •Unable to provide informed consent on their own behalf due to cognitive impairment
- •Pregnant or breastfeeding
研究组 & 干预措施
Patients with SOC image-guided intervention
Patients undergoing a standard of care (SOC) image-guided intervention of the head or body
干预措施: C-arm PCD-CBCT (Device)
结局指标
主要结局
Mean Confidence Score for Calcifications
时间窗: after participant data collection is complete (up to 1 year)
MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify calcifications and extravasated iodine contrast (if available) and provide a 1 (low) to 5 (high) confidence score on each image.
Mean Confidence Score for Metal Artifacts
时间窗: after participant data collection is complete (up to 1 year)
MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify metal artifacts (if any) and provide a 1 (low) to 5 (high) confidence score on each image.
Area Under the Curve (AUC) for Calcification Detection
时间窗: image analysis will proceed after participant data collection is complete (up to 2 years)
For all reading studies, the order of subjects and imaging modality (MDCT, FPD-CBCT, and PCD-CBCT) will be randomized; three separate reading sessions will be implemented with a washout period of at least 3 months between sessions. For calcification and iodine staining detection in the human subjects, the receiver operating characteristic (ROC) curves will be calculated using the maximum-likelihood method with the binormal model. The 95% confidence interval (CI) of each ROC curve will be estimated and the area under the curve (AUC) and its 95% CI will be calculated.
次要结局
未报告次要终点