Assessing the Clinical Acceptability of Ultra-low Dose PET/CT and CT-less PET Using a Long Axial Field-of-view PET/CT System: a Single-centre, Single-blinded Method Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Intra-rater correlation coefficient
研究概览
简要总结
Latest generation extended axial field-of-view (FOV) PET/CT systems offer the potential for substantial reductions in applied radiopharmaceutical necessary for a clinical scan. However, such low-dose examination protocols have yet to be robustly tested or demonstrated to be non-inferior. Furthermore, extended FOV scanners offer the potential for CT-less attenuation correction of the PET emission data, making clinically acceptable ultra-low dose examination protocols with radiation exposures of < 1 millisievert possible for the first time. The aim of this study is to demonstrate the clinical acceptability of such low and ultra-low dose scanning protocols in a head-to-head prospective study against a full-dose scan using a regular FOV system
详细描述
The first installation of a long-axial field-of-view (LAFOV) PET/CT system occurred in October 2020 at the department for nuclear medicine in Bern. This scanner along with recently introduced total-body scanners (TB-PET/CT) represent a substantial step forward in terms of nuclear medicine imaging technology. In conjunction with recent improvements in time-of-flight resolution and fully-digital detection technology, such systems offer surpassed sensitivity with improvements in image quality, lesion detection and diagnostic certainty. In contrast to LAFOV systems, standard axial field of view (SAFOV) scanners suffer from limited detection efficiency, where 90% of emitted photons go undetected owing to the ability to capture signal from only a small portion of the body (termed "bed position" or "bp").
However, while a number of studies are able to simulate lower applied radiopharmaceutical activities through the re-sampling of PET-sinogrammes or the rebinning of list-mode data, few studies adequately test the application of lower radiopharmaceutical activities, where limited data are available to justify the deviation from clinical routine. The clinical acceptability of such low-dose scans, in terms of lesion detection, image quality and lesion quantification is yet to be determined, which this study aims to address.
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
- None
盲法说明
Scan reviewers will be masked to dose and scan reconstruction method.
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
- •Adults (>18 years) able to provide informed consent for inclusion, willing and able to undergo a PET/CT for the detection or staging of cancer.
- •Individuals undergoing a PET/CT with 18F-FDG for the investigation of known or suspected NSCLC.
- •Upper fasting plasma glucose levels of <8.3 mmol/L (<150 mg/dL) (as measured >30 mins prior to the administration of the radiopharmaceutical).
排除标准
- •Patients who are unable to consent to a second study-specific examination
- •Patients with claustrophobia requiring medication.
- •Patients who commence active treatment of a cancer or other pathology between scans.
- •Patients who have not fasted for > 4 hours prior to the study.
- •Insulin dependent diabetics.
结局指标
主要结局
Intra-rater correlation coefficient
时间窗: 2-6 weeks following scan
ICC for Cancer Stage using the union for international cancer control (UICC) TNM (T= tumor, N= nodal stage, M = metastasis) System (8th Edition) for low dose positron emission and computed tomography (LD-PET/CT) exams compared to the standard of care (SOC) full-dose (FD)-PET/CT as assessed by a panel of physicians
次要结局
- Intra-rater correlation coefficient(2-6 weeks following scan)
- Lesion uptake(2-6 weeks following scan)
- Subjective quality(2-6 weeks following scan)
- Image quality(2-6 weeks following scan)
- Agreement(2-6 weeks following scan)
- Diagnostic accuracy(2-6 weeks following scan)