Low-dose AI-reconstructed CBCT Versus Full-dose CBCT for Guidance of Interventional Procedures: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,380
- 试验地点
- 5
- 主要终点
- Radiation dose
研究概览
简要总结
Cone Beam CT (CBCT) is an imaging modality used in interventional digital subtraction angiography (DSA). It produces three-dimensional images via cone-beam X-ray scanning and computer reconstruction. Clinically, CBCT guides puncture for pulmonary and hepatic lesions and evaluates post-intervention outcomes in liver cancer and cerebrovascular diseases. However, CBCT-guided interventions carry high patient radiation exposure; dose reduction often degrades image quality and impairs procedural results. Studies report that each 100 mGy radiation increment elevates cancer risk by 1.96-fold.
Artificial intelligence enables low-dose CBCT. Our prior DeepPriorCBCT model embedded anatomical priors using neural discrete representation learning, reducing thoracic CBCT dose to one-sixth of routine protocols while preserving image quality. We further developed DeepPriorCBCT-V2 using 55 000 pre-reconstruction CBCT datasets covering brain, thorax and abdomen. This multi-organ model maintains image quality at one-sixth standard radiation dose. Nevertheless, its real-world clinical performance remains unvalidated. We therefore designed this prospective multicenter randomized controlled trial to evaluate the clinical applicability of DeepPriorCBCT-V2.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 三盲 (受试者、研究者、结局评估者)
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
- Age ≥18 years.
- Requires CBCT-guided interventional treatment or surgery (e.g., cerebral angiography, lung puncture biopsy, hepatic artery chemoembolization, or percutaneous liver biopsy) and meets operational indications.
- Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.
- Requires CBCT-guided interventional treatment or surgery (e.g., cerebral angiography, lung puncture biopsy, hepatic artery chemoembolization, or percutaneous liver biopsy) and meets operational indications.
排除标准
- History of high-dose radiation exams or treatments.
- Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.
- Pregnant or breastfeeding women.
- Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency).
- Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.
- Participants are not suitable for the trial per investigator's opinion.
- Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.
- Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency).
- Pregnant or breastfeeding women.
- Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.
研究组 & 干预措施
Participants will receive interventional procedures guided by DeepPriorCBCT-V2.
Patients underwent interventional procedures guided by CBCT images reconstructed via the DeepPriorCBCT-V2 model from low-radiation-dose scans (1/6 of the conventional dose for the thorax and abdomen, and 1/5 for the brain).
干预措施: DeepPriorCBCT-V2 (Other)
Participants will receive interventional procedures guided by clinical standard protocol.
Patients underwent interventional procedures guided by CBCT images reconstructed via clinical standard protocol (full-radiation-dose).
干预措施: Clinical standard protocol (Full-radiation-dose CBCT) (Device)
结局指标
主要结局
Radiation dose
时间窗: Through study completion, an average of 5 months.
Air Kerma (AK) refers to the sum of the initial kinetic energies transferred from uncharged ionizing radiation (such as X-ray photons) to charged particles in air, divided by the mass of air at that location.
次要结局
- Operation time(Through study completion, an average of 5 months.)
- Intraoperative complications.(Through study completion, an average of 5 months.)
- Post operative complications(Through study completion, an average of 5 months.)
研究者
研究点 (5)
标识符
- NCT 编号
- NCT07845929
- 其他研究编号
- DeepPriorCBCT-V2
日期
- 首次提交
- (9天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (3个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否