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Completed

NCT Number: NCT00265356

Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)
  • 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
  • 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)
  • Age over 18 years

Exclusion criteria

  • Extrahepatic disease including enlarged portal lymph nodes on CT
  • Prior liver resection
  • Previous radiofrequency ablation of malignant liver lesion
  • Systemic chemotherapy within three weeks prior to randomization
  • Radiotherapy within two months prior to randomization
  • Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
  • Pregnant or lactating female
  • Unable to lie supine for imaging with PET
  • Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
  • Patients who, at the time of the initial evaluation, have already undergone a whole body PET within 6 months prior to randomization

Treatment and study plan

PET Diagnostic Imaging

Procedure

PET diagnostic imaging

Other names: Positron Emission Tomography

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET

    Time frame: 12 months

  2. 3-year overall survival of patients who undergo surgery with curative intent

    Time frame: 12 months

  3. 3-year overall survival of all patients

    Time frame: 12 months

  4. sensitivity and specificity of PET in detecting other hepatic and extra-hepatic metastatic disease prior to a potentially curable liver resection for colorectal adenocarcinoma metastatic disease

    Time frame: 12 months

  5. economic analysis of the addition of PET in the diagnostic work-up

    Time frame: 4 year

  6. prognostic ability of the PET standard uptake value (SUV) in predicting 3-year overall survival

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Official study title

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

Acronym: PETCAM

Important dates

Study start
2005
Primary completion
2010
Study completion
2013
First posted
Dec 14, 2005
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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