Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00119899|
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : August 31, 2005
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Liver Metastases Colorectal Cancer Neoplasm Metastasis||Procedure: FDG-PET scan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases|
|Study Start Date :||March 2002|
|Study Completion Date :||June 2005|
- Disease Free Survival (9 months)
- Economic evaluation (9 months)
- Disease Free Survival
- Overall Survival
- Change in Clinical Management
- Economic evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119899
|Veldhoven, Brabant, Netherlands|
|UMC ST Radboud|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Amsterdam, Noord Holland, Netherlands|
|Principal Investigator:||Wim JG Oyen, MD, Phd||Radboud University|