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Brief Title: Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases
Official Title: The Impact of Positron Emission Tomography (PET) Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases: A Prospective, Multicentre Randomized Clinical Trial
Study ID: NCT00265356
Brief Summary: The purpose of this trial is to improve the management of patients with potentially surgically curable colorectal cancer liver metastases. The primary objective is to determine the impact of pre-operative positron emission tomography (PET) on patients who have been assessed as having resectable colorectal cancer liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax, colonoscopy), by determining the proportion of patients who have a change in management resulting from PET.
Detailed Description: Colorectal cancer remains a leading cause of death in men and women. A significant number of patients with colorectal cancer will either present with, or subsequently develop, liver metastases. In contrast to many other epithelial solid tumours, resection of colorectal cancer hepatic metastases results in long-term survival and even cure. However, despite state of the art CT imaging, 60-75% of patients who appear to have limited disease amenable to surgical resection will eventually die from extra-hepatic and recurrent hepatic metastases. If occult micrometastatic disease that becomes evident after liver resection could be detected reliably during pre-operative assessment, patients harboring more widespread disease could be spared a non-curative liver resection. This is one of the present challenges of liver surgery. PET imaging has the potential to improve the detection of both hepatic and extra-hepatic metastatic disease, not detected by conventional imaging modalities. This prospective, multicenter trial will enroll patients with colorectal cancer liver metastases considered resectable, based on CT scans of the thorax, abdomen and pelvis, which demonstrate no evidence of extra-hepatic disease. A full colonoscopy within the preceding 12 months will ensure there is no local recurrence, or other primary cancer at the time of planned liver resection. These patients will be randomized to PET scan or not.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hamilton Health Sciences, Hamilton, Ontario, Canada
St. Joseph's Healthcare, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
London Health Sciences, London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
St. Joseph's Health Centre, Toronto, Ontario, Canada
Name: Steven Gallinger, MD
Affiliation: University Health Network: Mount Sinai Hospital
Role: STUDY_CHAIR
Name: Mark Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: PRINCIPAL_INVESTIGATOR
Name: Carol-anne Moulton, MD
Affiliation: University Health Network: Toronto General Hospital
Role: PRINCIPAL_INVESTIGATOR