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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Procedure: PET diagnostic imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences
    • Kingston, Ontario, Canada, K7L 5P9
      • Cancer Centre of Southeastern Ontario At Kingston General Hospital
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Regional Cancer Centre
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Regional Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada, M6R 1B5
      • St. Joseph's Health Centre
    • Toronto, Ontario, Canada, M5G 1X5
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; PET diagnostic imaging	Procedure: PET diagnostic imaging; PET diagnostic imaging; Other Names: Positron Emission Tomography
No Intervention: 2; No PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients who have a change in management resulting from PET	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET	12 months
3-year overall survival of patients who undergo surgery with curative intent	12 months
3-year overall survival of all patients	12 months
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	12 months
economic analysis of the addition of PET in the diagnostic work-up	4 year
prognostic ability of the PET standard uptake value (SUV) in predicting 3-year overall survival	12 months

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Study Chair: Steven Gallinger, MD, University Health Network: Mount Sinai Hospital; Principal Investigator: Carol-anne Moulton, MD, University Health Network: Toronto General Hospital

Publications and helpful links

General Publications

• Serrano PE, Gafni A, Gu CS, Gulenchyn KY, Julian JA, Law C, Hendler AL, Moulton CA, Gallinger S, Levine MN. Positron Emission Tomography-Computed Tomography (PET-CT) Versus No PET-CT in the Management of Potentially Resectable Colorectal Cancer Liver Metastases: Cost Implications of a Randomized Controlled Trial. J Oncol Pract. 2016 Jul;12(7):e765-74. doi: 10.1200/JOP.2016.011676. Epub 2016 Jun 21.
• Moulton CA, Gu CS, Law CH, Tandan VR, Hart R, Quan D, Fairfull Smith RJ, Jalink DW, Husien M, Serrano PE, Hendler AL, Haider MA, Ruo L, Gulenchyn KY, Finch T, Julian JA, Levine MN, Gallinger S. Effect of PET before liver resection on surgical management for colorectal adenocarcinoma metastases: a randomized clinical trial. JAMA. 2014 May 14;311(18):1863-9. doi: 10.1001/jama.2014.3740.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 12, 2005
• First Submitted That Met QC Criteria: December 12, 2005
• First Posted (Estimate): December 14, 2005

Study Record Updates

• Last Update Posted (Estimate): October 21, 2013
• Last Update Submitted That Met QC Criteria: October 18, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Colorectal cancer; Positron Emission Tomography (PET); Liver metastases; Liver surgery; Diagnostic Investigation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Adenocarcinoma
• Other Study ID Numbers: CTA-Control-098389