Know Cancer

forgot password

The Impact of Positron Emission Tomography (PET) Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases: A Prospective, Multicentre Randomized Clinical Trial

Phase 3
18 Years
Not Enrolling
Colorectal Cancer, Liver Metastases

Thank you

Trial Information

The Impact of Positron Emission Tomography (PET) Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases: A Prospective, Multicentre Randomized Clinical Trial

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

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.

Inclusion Criteria:

1. Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell
cancer, gastrointestinal stromal tumor, or lymphoma)

2. Contrast-enhanced spiral CT scan of the thorax, and a tri-phasic CT scan of the
abdomen and pelvis performed within 30 days (plus up to 14 days) before randomization
demonstrating resectable metastasis(es) that are isolated to the liver

3. Full colonoscopy performed within the preceding 18 months showing no evidence of
malignancy (other than a synchronous colorectal primary expected to be removed at
time of liver resection)

4. Age over 18 years

Exclusion Criteria:

1. Extrahepatic disease including enlarged portal lymph nodes on CT

2. Prior liver resection

3. Previous radiofrequency ablation of malignant liver lesion

4. Systemic chemotherapy within three weeks prior to randomization

5. Radiotherapy within two months prior to randomization

6. Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac
disease, significant chronic obstructive pulmonary disease) making the patient unfit
for surgery

7. Pregnant or lactating female

8. Unable to lie supine for imaging with PET

9. Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ
of the cervix, unless disease-free for 5 years or greater

10. Patients who, at the time of the initial evaluation, have already undergone a whole
body PET within 6 months prior to randomization

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

proportion of patients who have a change in management resulting from PET

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Steven Gallinger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Health Network: Mount Sinai Hospital


Canada: Health Canada

Study ID:




Start Date:

November 2005

Completion Date:

April 2013

Related Keywords:

  • Colorectal Cancer
  • Liver Metastases
  • Positron Emission Tomography (PET)
  • Diagnostic Investigation
  • Colorectal cancer
  • Liver metastases
  • Liver surgery
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms