PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
研究概览
简要总结
Hypothesis:
The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.
This study is a prospective single center study.
详细描述
Hypothesis
We would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility. This study allows us to assess the feasibility of such a large-scale study, but also to evaluate COMBI TEP performance. From these estimates, we can then consider a comparative study to evaluate the performance of COMBI PET.
This study is a prospective single center study.
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
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
- •Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:
- •Digestive cancers
- •Colorectal cancer
- •Preoperative evaluation in local and metastatic recurrence
- •Location of recurrences, in case of ACE increase in a previously operated patient.
- •Esophageal cancer: initial staging.
- •Pancreatic cancer
- •Initial staging,
- •Differential diagnosis with chronic pancreatitis.
- •Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
- •Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
- •Lung cancer
- •Initial staging,
- •Diagnosis of lung isolated lesion > 1 cm.
- •Head and neck cancer
- •Initial pretreatment staging,
- •Recurrence diagnosis
- •Initial staging of Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL) and aggressive follicular lymphomas,
- •Diagnosis of minimal residual disease of HD and aggressive NHL,
- •Early assessment of treatment response.
- •Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
- •Ovarian cancer recurrence
- •Age ≥ 18 years.
- •Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
- •Woman of childbearing age with negative pregnancy test and / or contraception.
- •Patient with informed consent signed.
- •Patient affiliated to social security schemes.
排除标准
- •Iodine known allergy.
- •Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
- •Known renal failure (creatinine clearance <60ml/min).
- •Indications against Xenetix ®:
- •Hypersensitivity to Xenetix ® or any of the excipients,
- •History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
- •Thyrotoxicosis.
- •Pregnant or lactating women.
- •Unable to undergo medical follow up for geographical, social or psychological reasons,
- •Private of freedom patient and adult under a legal guardianship or unable to consent.
研究组 & 干预措施
COMBI TEP : PET / enhanced CT scan
COMBI TEP : PET / enhanced CT scan
干预措施: COMBI TEP : PET / enhanced CT scan (Device)
结局指标
主要结局
Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
时间窗: 1 year
The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient \[ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.\].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study
次要结局
- Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level(1 year)
- Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions(1 year)
- Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level(1 year)
- Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions(1 year)
- Intra-observer Reproducibility of Injected CT Scanat a Patient Level(1 year)