Benefits Study of a Respiratory Gating Protocol for 18F-FDG PET: Application on the Liver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Detected Uptakes on PET Images
研究概览
简要总结
Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion and because the liver is intrinsically FDG avid, some tumours (especially the smallest ones) can be occulted and missed by the clinician.
The investigators developed a respiratory-gated PET method in order to reduce the motion issue. This protocol has been validated on lung pathologies. The investigators designed a study to investigate its effect on liver cancer (primary or metastasis) to check if it allows the detection of a higher number of tumour lesions.
To that aim, patients who are planned to undergo a surgical intervention on the liver can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.
详细描述
Introduction:
18-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) became a major imaging modality for management of patients with suspected hepatic cancer notably because of its ability to detect distant metastases. Hepatic resection is known to be the only curative treatment in a subset of patients suffering liver neoplasm. Eligibility for hepatic surgery lays on conventional staging comprising contrast-enhanced CT, magnetic resonance imaging or ultrasonography of the liver. Recently, 18F-FGD PET/CT has been introduced as a staging modality in the preoperative work up.
However, many physiological issues could affect PET interpretation. Indeed, some lesions could be missed by the physician due to histology of the lesion (e.g. in case of moderate or well-differentiated hepatocellular carcinoma (HCC) or mucinous carcinoma). Unlike, local inflammations could be wrongly considered as malignant.
Another issue for liver examination with PET imaging is the respiratory motion as it produces blurring in reconstructed images. Therefore, some lesions may be missed or underestimated. This motion issue is well known for thoracic imaging and various methods were proposed to deal with it. We have developed a respiratory motion compensation method where gated PET events are selected on the base of a breath-hold CT (CT-based).
To our knowledge, no sensitivity study was performed to assess the usefulness of gated acquisitions in term of lesions detection at abdominal stage. W In this trial, we apply our gating method on the liver to compare lesion-per-lesion sensitivity of clinical (Ungated) and CT-based PET images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •patient planed to undergo any liver surgical intervention
- •age : over 18
- •patients gave their written informed consent
排除标准
- •pregnancy
- •liver surgical intervention cancel upon surgical or medical decision
结局指标
主要结局
Number of Detected Uptakes on PET Images
时间窗: day 1
Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).
次要结局
- Lesions Uptake Measurement (SUVmax)(Day 1)