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临床试验/NCT00119899
NCT00119899已完成3 期

Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases

Radboud University Medical Center5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2002年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
150
试验地点
5
主要终点
Disease Free Survival (9 months)

研究概览

简要总结

Objective(s) of the proposed study:

  • The evaluation of the efficiency of 18F deoxyglucose-Positron Emission Tomography (FDG-PET) in staging patients eligible for hepatic resection of colorectal liver metastases in a randomized clinical multicentre setting.

Research questions of the proposed study:

  • What are the effects and costs for patients with liver metastases of colorectal cancer indicated for potentially curative hepatic resection, using the conventional diagnostic strategy with computed tomography (CT) scan in comparison to the experimental diagnostic strategy incorporating FDG-PET scan (CT + FDG-PET scan), based on a health care perspective and a time horizon of 9 months.

More specifically:

  • Does the experimental diagnostic strategy which includes FDG-PET scan in the diagnostic work-up of patients eligible for potentially curative hepatic resection of colorectal liver metastases lead to a better disease-free survival at 9 months after hepatic resection in comparison to the conventional diagnostic strategy using CT scan without FDG-PET scan.
  • What are the costs of diagnostic and therapeutic care for the two diagnostic strategies for patients eligible for potentially curative hepatic resection of colorectal liver metastases.
  • What is the effect of including the FDG-PET scan in the diagnostic work-up of patients eligible for potentially curative hepatic resection of colorectal liver metastases after hepatic resection, expressed as disease-free survival at 9 months adjusted for quality of health (Q-TWIST), in comparison to the use of CT scan only.

详细描述

Study design:

Prospective randomized study. In both arms conventional diagnostic tests will be performed. In arm A (conventional strategy) no FDG-PET scan will be performed. In arm B (experimental strategy) an FDG-PET scan will be made and the results will be incorporated in decisions for further clinical management by the referring surgeon.

Motivation study design:

Randomization in one strategy with and one strategy without FDG-PET scan will allow to truly estimate the impact of including FDG-PET scan in the diagnostic work-up. More specifically this study design allows to determine:

  1. The impact of FDG-PET on disease-free survival after hepatic resection.
  2. The amount and costs of diagnostic and (non)-therapeutic procedures of both strategies.
  3. The average number of months of disease-free survival adjusted for quality of health (Q-TWIST) for the two strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • One to four colorectal liver metastases on spiral CT, judged potentially resectable by an experienced liver surgeon from the institution participating in the trial.
  • WHO performance status 0, 1 or
  • Age 18-75 years
  • Written informed consent
  • Exclusion Criteria
  • Evidence of extrahepatic disease as demonstrated by spiral CT scan of chest and abdomen with oral and intravenous contrast with contiguous reconstruction algorithm. In case of previous rectal cancer spiral CT should include the pelvic area. CT readings should be performed by an experienced radiologist from the institution participating in the trial.
  • Signs of recurrent or second colorectal carcinoma on barium enema or colonoscopy.
  • Any other previous malignancy other than adequately treated in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 10 years).
  • Major hepatic insufficiency.
  • Active infection and diabetes mellitus

排除标准

  • 未提供

结局指标

主要结局

Disease Free Survival (9 months)

Economic evaluation (9 months)

次要结局

  • Disease Free Survival
  • Overall Survival
  • Change in Clinical Management
  • Economic evaluation

研究者

申办方类型
Other

研究点 (5)

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