Status:
COMPLETED
Utility of FDG-PET Scan on the Selection of Patients for Resection of Hepatic Colorectal Metastases
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Amsterdam UMC, location VUmc
University Medical Center Groningen
Conditions:
Colorectal Liver Metastases
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 live...
Detailed Description
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 st...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 2.
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00119899
Start Date
March 1 2002
End Date
June 1 2005
Last Update
August 31 2005
Active Locations (4)
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1
UMC ST Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
2
MMC
Veldhoven, North Brabant, Netherlands
3
UMCVU
Amsterdam, North Holland, Netherlands
4
UMCG
Groningen, Provincie Groningen, Netherlands